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Spray-dried plasma inches toward clinical trials
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
hematologynews@frontlinemedcom.com
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
hematologynews@frontlinemedcom.com
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
hematologynews@frontlinemedcom.com
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
REPORTING FROM AABB 17
Key clinical point:
Major finding: Spray-dried plasma was equal to, or superior to, fresh frozen plasma in many of the in vitro assays utilized, especially when pretreated in glycine solutions.
Study details: Two in vitro assays that compared spray-dried plasma with fresh frozen plasma.
Disclosures: Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
Sources: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
Zika RNA persists in blood components after clearance from plasma
SAN DIEGO – Zika virus can persist in blood components for several months, long after it is no longer detectable in plasma and other body fluids, based on data reported at the annual meeting of the American Association of Blood Banks.
The presence of Zika virus in plasma declined rapidly following donation, but could be detected in red blood cells (RBCs) and whole blood for up to 3 months. In addition, the virus was also detected intermittently in peripheral blood mononuclear cells (PBMCs) at low levels after clearance from plasma.
“There was longer persistence of Zika RNA in whole blood and RBC blood components than in plasma and other body fluids. It was detected at high levels and persists for about 6 weeks,” Mars Stone, PhD said in presenting the findings.
The findings were based on 2016 data collected in Puerto Rico, which began screening blood donations for Zika virus RNA under an investigational protocol by using a nucleic acid test; they began doing so as a result of guidance from the U.S. Food and Drug Administration. Approximately 350 confirmed infected – that is, nucleic acid test positive (NAT+) – donations were detected through December 2016.
The FDA approved the cobas Zika test used in the study on October 5. Intended for use by blood collection establishments to detect Zika virus in blood donations, the test is manufactured by Roche Molecular Systems. Dr. Stone is an employee of Blood Systems Research Institute, a confirmatory laboratory for Roche.
Of the 52,942 donations collected between April 3 and Dec. 31, 352 were reactive for ZIKV RNA. Plasma from blood donors was screened by individual donation NAT for the presence of ZIKV RNA with the cobas Zika test. At an interval of between 57 and 120 days, no Zika RNA was found in 350 samples of plasma, but it was found in 38.2% (34 samples) of RBCs and 40.0% (35 samples) of whole blood.
In urine and saliva, the virus was detected in high levels at 1-2 weeks, but then rapidly waned. In semen, it was detected at high levels and persisted for about 6 weeks.
“But despite the huge epidemics in Latin America, Puerto Rico, and the other Caribbean islands, there have been no cases of transfusion-related infections linked to RBC transfusions when plasma NAT screening was negative,” said Dr. Stone. “So we are tentatively confirming that red cell–associated virus is not infectious and that plasma NAT screening is likely sufficient.”
The authors point out that RNA persistence has been reported in whole blood long after the virus cleared from plasma and therefore have raised concerns about the risk of transfusion-related viral transmission. The goal of the current study was to characterize the dynamics of infection using donors who were infected with Zika virus.
To date there are 56 donors enrolled in the study, primarily male and from Puerto Rico. Most of them are also positive for dengue fever, Dr. Stone pointed out. “The epidemic in Puerto Rico reached peak in June 2016 but has very little activity this year.”
Plasma and RBCs were collected from index donations, while blood, urine, saliva, and semen samples were collected prospectively at weeks 1, 3, 6, 12, and 24 following index donations. Blood compartments and body fluids were tested for Zika RNA by real time reverse transcription polymerase chain reaction testing, and plasma samples were tested for Zika-specific immunoglobulin M and immunoglobulin G antibodies.
In plasma, Zika virus RNA rapidly decreased after index donations but persisted for up to 3 months in RBCs and whole blood. In peripheral blood mononuclear cells, Zika virus was detected intermittently at low levels but waned by 3 months. In peripheral blood mononuclear cells, Zika RNA was detected in 5.9% (17 samples) at 121-196 days.
Among donors who entered the study while in the acute preseroconversion stage of infection, 65% developed Zika virus symptoms at 1 week post index donation, compared with 30% of donors detected after seroconversion.
The study was funded by the U.S. Department of Health & Human Services.
SAN DIEGO – Zika virus can persist in blood components for several months, long after it is no longer detectable in plasma and other body fluids, based on data reported at the annual meeting of the American Association of Blood Banks.
The presence of Zika virus in plasma declined rapidly following donation, but could be detected in red blood cells (RBCs) and whole blood for up to 3 months. In addition, the virus was also detected intermittently in peripheral blood mononuclear cells (PBMCs) at low levels after clearance from plasma.
“There was longer persistence of Zika RNA in whole blood and RBC blood components than in plasma and other body fluids. It was detected at high levels and persists for about 6 weeks,” Mars Stone, PhD said in presenting the findings.
The findings were based on 2016 data collected in Puerto Rico, which began screening blood donations for Zika virus RNA under an investigational protocol by using a nucleic acid test; they began doing so as a result of guidance from the U.S. Food and Drug Administration. Approximately 350 confirmed infected – that is, nucleic acid test positive (NAT+) – donations were detected through December 2016.
The FDA approved the cobas Zika test used in the study on October 5. Intended for use by blood collection establishments to detect Zika virus in blood donations, the test is manufactured by Roche Molecular Systems. Dr. Stone is an employee of Blood Systems Research Institute, a confirmatory laboratory for Roche.
Of the 52,942 donations collected between April 3 and Dec. 31, 352 were reactive for ZIKV RNA. Plasma from blood donors was screened by individual donation NAT for the presence of ZIKV RNA with the cobas Zika test. At an interval of between 57 and 120 days, no Zika RNA was found in 350 samples of plasma, but it was found in 38.2% (34 samples) of RBCs and 40.0% (35 samples) of whole blood.
In urine and saliva, the virus was detected in high levels at 1-2 weeks, but then rapidly waned. In semen, it was detected at high levels and persisted for about 6 weeks.
“But despite the huge epidemics in Latin America, Puerto Rico, and the other Caribbean islands, there have been no cases of transfusion-related infections linked to RBC transfusions when plasma NAT screening was negative,” said Dr. Stone. “So we are tentatively confirming that red cell–associated virus is not infectious and that plasma NAT screening is likely sufficient.”
The authors point out that RNA persistence has been reported in whole blood long after the virus cleared from plasma and therefore have raised concerns about the risk of transfusion-related viral transmission. The goal of the current study was to characterize the dynamics of infection using donors who were infected with Zika virus.
To date there are 56 donors enrolled in the study, primarily male and from Puerto Rico. Most of them are also positive for dengue fever, Dr. Stone pointed out. “The epidemic in Puerto Rico reached peak in June 2016 but has very little activity this year.”
Plasma and RBCs were collected from index donations, while blood, urine, saliva, and semen samples were collected prospectively at weeks 1, 3, 6, 12, and 24 following index donations. Blood compartments and body fluids were tested for Zika RNA by real time reverse transcription polymerase chain reaction testing, and plasma samples were tested for Zika-specific immunoglobulin M and immunoglobulin G antibodies.
In plasma, Zika virus RNA rapidly decreased after index donations but persisted for up to 3 months in RBCs and whole blood. In peripheral blood mononuclear cells, Zika virus was detected intermittently at low levels but waned by 3 months. In peripheral blood mononuclear cells, Zika RNA was detected in 5.9% (17 samples) at 121-196 days.
Among donors who entered the study while in the acute preseroconversion stage of infection, 65% developed Zika virus symptoms at 1 week post index donation, compared with 30% of donors detected after seroconversion.
The study was funded by the U.S. Department of Health & Human Services.
SAN DIEGO – Zika virus can persist in blood components for several months, long after it is no longer detectable in plasma and other body fluids, based on data reported at the annual meeting of the American Association of Blood Banks.
The presence of Zika virus in plasma declined rapidly following donation, but could be detected in red blood cells (RBCs) and whole blood for up to 3 months. In addition, the virus was also detected intermittently in peripheral blood mononuclear cells (PBMCs) at low levels after clearance from plasma.
“There was longer persistence of Zika RNA in whole blood and RBC blood components than in plasma and other body fluids. It was detected at high levels and persists for about 6 weeks,” Mars Stone, PhD said in presenting the findings.
The findings were based on 2016 data collected in Puerto Rico, which began screening blood donations for Zika virus RNA under an investigational protocol by using a nucleic acid test; they began doing so as a result of guidance from the U.S. Food and Drug Administration. Approximately 350 confirmed infected – that is, nucleic acid test positive (NAT+) – donations were detected through December 2016.
The FDA approved the cobas Zika test used in the study on October 5. Intended for use by blood collection establishments to detect Zika virus in blood donations, the test is manufactured by Roche Molecular Systems. Dr. Stone is an employee of Blood Systems Research Institute, a confirmatory laboratory for Roche.
Of the 52,942 donations collected between April 3 and Dec. 31, 352 were reactive for ZIKV RNA. Plasma from blood donors was screened by individual donation NAT for the presence of ZIKV RNA with the cobas Zika test. At an interval of between 57 and 120 days, no Zika RNA was found in 350 samples of plasma, but it was found in 38.2% (34 samples) of RBCs and 40.0% (35 samples) of whole blood.
In urine and saliva, the virus was detected in high levels at 1-2 weeks, but then rapidly waned. In semen, it was detected at high levels and persisted for about 6 weeks.
“But despite the huge epidemics in Latin America, Puerto Rico, and the other Caribbean islands, there have been no cases of transfusion-related infections linked to RBC transfusions when plasma NAT screening was negative,” said Dr. Stone. “So we are tentatively confirming that red cell–associated virus is not infectious and that plasma NAT screening is likely sufficient.”
The authors point out that RNA persistence has been reported in whole blood long after the virus cleared from plasma and therefore have raised concerns about the risk of transfusion-related viral transmission. The goal of the current study was to characterize the dynamics of infection using donors who were infected with Zika virus.
To date there are 56 donors enrolled in the study, primarily male and from Puerto Rico. Most of them are also positive for dengue fever, Dr. Stone pointed out. “The epidemic in Puerto Rico reached peak in June 2016 but has very little activity this year.”
Plasma and RBCs were collected from index donations, while blood, urine, saliva, and semen samples were collected prospectively at weeks 1, 3, 6, 12, and 24 following index donations. Blood compartments and body fluids were tested for Zika RNA by real time reverse transcription polymerase chain reaction testing, and plasma samples were tested for Zika-specific immunoglobulin M and immunoglobulin G antibodies.
In plasma, Zika virus RNA rapidly decreased after index donations but persisted for up to 3 months in RBCs and whole blood. In peripheral blood mononuclear cells, Zika virus was detected intermittently at low levels but waned by 3 months. In peripheral blood mononuclear cells, Zika RNA was detected in 5.9% (17 samples) at 121-196 days.
Among donors who entered the study while in the acute preseroconversion stage of infection, 65% developed Zika virus symptoms at 1 week post index donation, compared with 30% of donors detected after seroconversion.
The study was funded by the U.S. Department of Health & Human Services.
AT AABB17
Key clinical point: Zika virus can persist in cellular blood components for months after clearance from plasma.
Major finding: Plasma viremia rapidly declined after index donations, but
Data source: Zika RNA persistence in blood components after clearance of viremia in plasma was evaluated in 56 donors positive for Zika virus.
Disclosures: Dr. Stone is an employee of Blood Systems Research Institute in San Francisco, a confirmatory laboratory for Roche Molecular Systems, which manufactures the testing device used. The study was funded by the U.S. Department of Health & Human Services.
Source: Stone M et al. AABB 2017 Abstract C9-A01AC.
Zika virus testing shows low incidence in donor blood outside of high-infection areas
SAN DIEGO – The Zika virus is primarily transmitted via the Aedes mosquitoes, most commonly by A. aegypti, but recent outbreaks have revealed that nonvector transmission routes may also spread the infection. Some data suggest that blood transfusion can be a source of transmission.
While the number of contaminated blood donations remains very small, three studies presented at the American Association of Blood Banks annual meeting confirmed the ability of new investigational assays to detect Zika virus in donated blood.
There have been no confirmed transfusion-transmission cases of Zika virus in the United States, but as cases have now been documented in Brazil, the Food and Drug Administration issued revised guidance in August 2016 recommending that blood centers in all states and U.S. territories screen individual units of donated whole blood and blood components.
In the first report (C7-A01C), Paula Saá, PhD, and her colleagues at the American Red Cross initially investigated the use of mini-pool (MP)- nucleic acid testing (NAT) using the Procleix Zika Virus Assay (TMA). Testing was initially implemented on blood collections from Florida, Georgia, South Carolina, Mississippi, and Alabama – five states that were presumed to be at high risk of Zika virus infection. After the FDA revised its guidance, the protocol changed and testing was extended to all blood donations. The use of the MP-NAT was also converted to individual donation (ID)-NAT, and questions concerning travel history was also eventually discontinued.
However, even with the use of ID-NAT, the rate of confirmed positive donations was quite small but the associated cost was quite high, the researchers pointed out. “In the first year of testing at the American Red Cross, we identified nine confirmed positive donations,” said Dr. Saá.
The rate of confirmed positive donations was 1:354, 602 during the study period, but if the period up until September 2017 is taken into account (no additional cases were identified), the rate increases to 1:514,266. “This is a very low rate,” Dr. Saá said. “If there are no changes to the current guidelines, we have estimated that the yearly cost for the American Red Cross of testing will exceed $48 million.”
These figures extrapolate to approximately $6 million per confirmed case, according to the results of this study sponsored by the American Red Cross.
Confirmatory testing included repeat TMA; in addition, RT-PCR, serology and red blood cell count (RBC) TMA were performed. Estimates of viral loads were performed by endpoint TMA on plasma and RBCs.
A total of 2,288,855 blood donations had been tested as of April 2017, including 393,713 (17%) in 24,611 MPs, which did not detect any reactive donations.
Of the confirmed positive blood donors, three lived in Florida and two of those were from local transmission. Six individuals had traveled to a region highly active for Zika virus, and returned to the United States between 2 and 73 days before donating blood. Clinical symptoms were reported in two individuals with a travel risk; the other donors with a confirmed positive test (75%) remained asymptomatic. The longest period for detection in RBCs was 91 days thus far, but in the same person, detection in plasma was only 17 days.
“The data that we are showing here recommends a testing strategy with mini pool testing in areas at low risk of Zika transmission,” said Dr. Saá.
A second related study (C9-A01C), described the detection of ZIKV RNA in blood donations collected in U.S. states between April 3, 2016, and September 23, 2017, using the cobas Zika test, to be used on the cobas 6800/8800 Systems.
Although the test was investigational during the study period, it has just been approved by the FDA, said study author Lisa Pate, MD, who is with Roche Molecular Systems, the manufacturer of the cobas Zika test and cobas 6800/8800 systems. “This is now the first licensed test for screening blood donations for Zika virus.”
Overall, testing showed that Zika contamination in the U.S. blood supply was quite low. Only 0.001% of screened blood donations in United States were confirmed as true positives.
The development of this test came about after the first cases of Zika virus in the United States were detected in Puerto Rico in December 2015, explained Dr. Pate. Shortly after that, the FDA issued guidance prohibiting the use of blood collected in Zika active areas, unless the donations were screened.
“The impact was significant in Puerto Rico, as blood donations were halted, which then forced Puerto Rico to rely on imported blood,” she said.
About that time the FDA reached out to Roche and competitors to see if a test could be developed to screen for Zika.
The cobas Zika test was approved under an investigational new drug application on March 30, 2016, and although initially used to test blood samples in Puerto Rico, testing was expanded to include donor blood from all over the country.
Screening was conducted by individual donation testing, with all initial reactive results repeated in duplicate. Supplemental testing was also done, and included an alternative NAT (AltNAT) assay which was considered to be less sensitive than cobas Zika and serology testing for anti-Zika IgM and IgG. A donor confirmed Zika confirmed positive if at least one replicate of the repeat testing by cobas Zika was reactive on index donation or follow-up, reactive by AltNAT on the index donation, or positive for anti-Zika IgM on index or follow-up.
Screening was conducted at 12 testing labs in the United States, and more than 4 million donations were screened and 27 positive donations were confirmed. Overall, that amounted to less than 1 in 100,000.
“For donors in the U.S. with confirmed positive results, and for whom follow-up information is available, 84% of them report recent travel to Zika active areas,” noted Dr. Pate.
For Puerto Rico, 111,842 blood donations were screened and there were 356 confirmed positive results. The incidence is much higher than in United States, and was 1.27% during peak incidence in July 2016.
A third paper (C12-A01C), also reported on testing the blood supply in Singapore, which had reported its first locally transmitted Zika case last August, using the investigational Procleix ZIKV nucleic acid technology (NAT) assay.
The presence of Zika virus in screened blood was also quite low, with an incidence of only 0.0032%. The Procleix ZIKV assay was found to suitable for screening for Zika infection in an asymptomatic population, as it showed good analytical sensitivity and clinical performance.
The Zika virus came to Singapore in May 2016, imported by an individual who had recently traveled to Brazil, said Sally Lam, laboratory director, Blood Services Group, Health Sciences Authority, Singapore.
“Then in August we had 41 confirmed local Zika virus cases,” she said.
In 2016, there were 458 clinical Zika cases reported, with 8 clusters identified. This year, 63 cases have been reported to date, she said.
Mandatory Zika virus screening in donor blood with ID-NAT began after the onset of local outbreaks, and was implemented in January 2017. A total of 126,906 blood donations were screened.
Researchers in Singapore assessed the performance of the Procleix ZIKV NAT assay for universal blood donation screening. They screened all blood that was donated, beginning Oct. 1, 2016, a confirmed case was defined as having Zika RNA by PCR and/or Zika antibodies. Analytical sensitivity was assessed by use of 300 blinded frozen samples containing Zika virus and 25 negative controls. The performance of the Procleix ZIKV assay was also evaluated by use of samples from the local patient population.
Of four confirmed positive cases, only one was available for follow-up. “In the index donation, the viral load was quite high in the plasma but at 10 days, it was reduced to about 400 copies/mL in the plasma,” said Ms. Lam. “The donor did not develop any symptoms.”
The analytical sensitivity for the Procleix ZIKV assay was determined to be 2.1 copies/mL at 50% LOD and 10.0 copies/mL at 95% LOD, and it detected RNA in six out of nine patient samples for an 85.7% agreement with reference material, according to the researchers.
SAN DIEGO – The Zika virus is primarily transmitted via the Aedes mosquitoes, most commonly by A. aegypti, but recent outbreaks have revealed that nonvector transmission routes may also spread the infection. Some data suggest that blood transfusion can be a source of transmission.
While the number of contaminated blood donations remains very small, three studies presented at the American Association of Blood Banks annual meeting confirmed the ability of new investigational assays to detect Zika virus in donated blood.
There have been no confirmed transfusion-transmission cases of Zika virus in the United States, but as cases have now been documented in Brazil, the Food and Drug Administration issued revised guidance in August 2016 recommending that blood centers in all states and U.S. territories screen individual units of donated whole blood and blood components.
In the first report (C7-A01C), Paula Saá, PhD, and her colleagues at the American Red Cross initially investigated the use of mini-pool (MP)- nucleic acid testing (NAT) using the Procleix Zika Virus Assay (TMA). Testing was initially implemented on blood collections from Florida, Georgia, South Carolina, Mississippi, and Alabama – five states that were presumed to be at high risk of Zika virus infection. After the FDA revised its guidance, the protocol changed and testing was extended to all blood donations. The use of the MP-NAT was also converted to individual donation (ID)-NAT, and questions concerning travel history was also eventually discontinued.
However, even with the use of ID-NAT, the rate of confirmed positive donations was quite small but the associated cost was quite high, the researchers pointed out. “In the first year of testing at the American Red Cross, we identified nine confirmed positive donations,” said Dr. Saá.
The rate of confirmed positive donations was 1:354, 602 during the study period, but if the period up until September 2017 is taken into account (no additional cases were identified), the rate increases to 1:514,266. “This is a very low rate,” Dr. Saá said. “If there are no changes to the current guidelines, we have estimated that the yearly cost for the American Red Cross of testing will exceed $48 million.”
These figures extrapolate to approximately $6 million per confirmed case, according to the results of this study sponsored by the American Red Cross.
Confirmatory testing included repeat TMA; in addition, RT-PCR, serology and red blood cell count (RBC) TMA were performed. Estimates of viral loads were performed by endpoint TMA on plasma and RBCs.
A total of 2,288,855 blood donations had been tested as of April 2017, including 393,713 (17%) in 24,611 MPs, which did not detect any reactive donations.
Of the confirmed positive blood donors, three lived in Florida and two of those were from local transmission. Six individuals had traveled to a region highly active for Zika virus, and returned to the United States between 2 and 73 days before donating blood. Clinical symptoms were reported in two individuals with a travel risk; the other donors with a confirmed positive test (75%) remained asymptomatic. The longest period for detection in RBCs was 91 days thus far, but in the same person, detection in plasma was only 17 days.
“The data that we are showing here recommends a testing strategy with mini pool testing in areas at low risk of Zika transmission,” said Dr. Saá.
A second related study (C9-A01C), described the detection of ZIKV RNA in blood donations collected in U.S. states between April 3, 2016, and September 23, 2017, using the cobas Zika test, to be used on the cobas 6800/8800 Systems.
Although the test was investigational during the study period, it has just been approved by the FDA, said study author Lisa Pate, MD, who is with Roche Molecular Systems, the manufacturer of the cobas Zika test and cobas 6800/8800 systems. “This is now the first licensed test for screening blood donations for Zika virus.”
Overall, testing showed that Zika contamination in the U.S. blood supply was quite low. Only 0.001% of screened blood donations in United States were confirmed as true positives.
The development of this test came about after the first cases of Zika virus in the United States were detected in Puerto Rico in December 2015, explained Dr. Pate. Shortly after that, the FDA issued guidance prohibiting the use of blood collected in Zika active areas, unless the donations were screened.
“The impact was significant in Puerto Rico, as blood donations were halted, which then forced Puerto Rico to rely on imported blood,” she said.
About that time the FDA reached out to Roche and competitors to see if a test could be developed to screen for Zika.
The cobas Zika test was approved under an investigational new drug application on March 30, 2016, and although initially used to test blood samples in Puerto Rico, testing was expanded to include donor blood from all over the country.
Screening was conducted by individual donation testing, with all initial reactive results repeated in duplicate. Supplemental testing was also done, and included an alternative NAT (AltNAT) assay which was considered to be less sensitive than cobas Zika and serology testing for anti-Zika IgM and IgG. A donor confirmed Zika confirmed positive if at least one replicate of the repeat testing by cobas Zika was reactive on index donation or follow-up, reactive by AltNAT on the index donation, or positive for anti-Zika IgM on index or follow-up.
Screening was conducted at 12 testing labs in the United States, and more than 4 million donations were screened and 27 positive donations were confirmed. Overall, that amounted to less than 1 in 100,000.
“For donors in the U.S. with confirmed positive results, and for whom follow-up information is available, 84% of them report recent travel to Zika active areas,” noted Dr. Pate.
For Puerto Rico, 111,842 blood donations were screened and there were 356 confirmed positive results. The incidence is much higher than in United States, and was 1.27% during peak incidence in July 2016.
A third paper (C12-A01C), also reported on testing the blood supply in Singapore, which had reported its first locally transmitted Zika case last August, using the investigational Procleix ZIKV nucleic acid technology (NAT) assay.
The presence of Zika virus in screened blood was also quite low, with an incidence of only 0.0032%. The Procleix ZIKV assay was found to suitable for screening for Zika infection in an asymptomatic population, as it showed good analytical sensitivity and clinical performance.
The Zika virus came to Singapore in May 2016, imported by an individual who had recently traveled to Brazil, said Sally Lam, laboratory director, Blood Services Group, Health Sciences Authority, Singapore.
“Then in August we had 41 confirmed local Zika virus cases,” she said.
In 2016, there were 458 clinical Zika cases reported, with 8 clusters identified. This year, 63 cases have been reported to date, she said.
Mandatory Zika virus screening in donor blood with ID-NAT began after the onset of local outbreaks, and was implemented in January 2017. A total of 126,906 blood donations were screened.
Researchers in Singapore assessed the performance of the Procleix ZIKV NAT assay for universal blood donation screening. They screened all blood that was donated, beginning Oct. 1, 2016, a confirmed case was defined as having Zika RNA by PCR and/or Zika antibodies. Analytical sensitivity was assessed by use of 300 blinded frozen samples containing Zika virus and 25 negative controls. The performance of the Procleix ZIKV assay was also evaluated by use of samples from the local patient population.
Of four confirmed positive cases, only one was available for follow-up. “In the index donation, the viral load was quite high in the plasma but at 10 days, it was reduced to about 400 copies/mL in the plasma,” said Ms. Lam. “The donor did not develop any symptoms.”
The analytical sensitivity for the Procleix ZIKV assay was determined to be 2.1 copies/mL at 50% LOD and 10.0 copies/mL at 95% LOD, and it detected RNA in six out of nine patient samples for an 85.7% agreement with reference material, according to the researchers.
SAN DIEGO – The Zika virus is primarily transmitted via the Aedes mosquitoes, most commonly by A. aegypti, but recent outbreaks have revealed that nonvector transmission routes may also spread the infection. Some data suggest that blood transfusion can be a source of transmission.
While the number of contaminated blood donations remains very small, three studies presented at the American Association of Blood Banks annual meeting confirmed the ability of new investigational assays to detect Zika virus in donated blood.
There have been no confirmed transfusion-transmission cases of Zika virus in the United States, but as cases have now been documented in Brazil, the Food and Drug Administration issued revised guidance in August 2016 recommending that blood centers in all states and U.S. territories screen individual units of donated whole blood and blood components.
In the first report (C7-A01C), Paula Saá, PhD, and her colleagues at the American Red Cross initially investigated the use of mini-pool (MP)- nucleic acid testing (NAT) using the Procleix Zika Virus Assay (TMA). Testing was initially implemented on blood collections from Florida, Georgia, South Carolina, Mississippi, and Alabama – five states that were presumed to be at high risk of Zika virus infection. After the FDA revised its guidance, the protocol changed and testing was extended to all blood donations. The use of the MP-NAT was also converted to individual donation (ID)-NAT, and questions concerning travel history was also eventually discontinued.
However, even with the use of ID-NAT, the rate of confirmed positive donations was quite small but the associated cost was quite high, the researchers pointed out. “In the first year of testing at the American Red Cross, we identified nine confirmed positive donations,” said Dr. Saá.
The rate of confirmed positive donations was 1:354, 602 during the study period, but if the period up until September 2017 is taken into account (no additional cases were identified), the rate increases to 1:514,266. “This is a very low rate,” Dr. Saá said. “If there are no changes to the current guidelines, we have estimated that the yearly cost for the American Red Cross of testing will exceed $48 million.”
These figures extrapolate to approximately $6 million per confirmed case, according to the results of this study sponsored by the American Red Cross.
Confirmatory testing included repeat TMA; in addition, RT-PCR, serology and red blood cell count (RBC) TMA were performed. Estimates of viral loads were performed by endpoint TMA on plasma and RBCs.
A total of 2,288,855 blood donations had been tested as of April 2017, including 393,713 (17%) in 24,611 MPs, which did not detect any reactive donations.
Of the confirmed positive blood donors, three lived in Florida and two of those were from local transmission. Six individuals had traveled to a region highly active for Zika virus, and returned to the United States between 2 and 73 days before donating blood. Clinical symptoms were reported in two individuals with a travel risk; the other donors with a confirmed positive test (75%) remained asymptomatic. The longest period for detection in RBCs was 91 days thus far, but in the same person, detection in plasma was only 17 days.
“The data that we are showing here recommends a testing strategy with mini pool testing in areas at low risk of Zika transmission,” said Dr. Saá.
A second related study (C9-A01C), described the detection of ZIKV RNA in blood donations collected in U.S. states between April 3, 2016, and September 23, 2017, using the cobas Zika test, to be used on the cobas 6800/8800 Systems.
Although the test was investigational during the study period, it has just been approved by the FDA, said study author Lisa Pate, MD, who is with Roche Molecular Systems, the manufacturer of the cobas Zika test and cobas 6800/8800 systems. “This is now the first licensed test for screening blood donations for Zika virus.”
Overall, testing showed that Zika contamination in the U.S. blood supply was quite low. Only 0.001% of screened blood donations in United States were confirmed as true positives.
The development of this test came about after the first cases of Zika virus in the United States were detected in Puerto Rico in December 2015, explained Dr. Pate. Shortly after that, the FDA issued guidance prohibiting the use of blood collected in Zika active areas, unless the donations were screened.
“The impact was significant in Puerto Rico, as blood donations were halted, which then forced Puerto Rico to rely on imported blood,” she said.
About that time the FDA reached out to Roche and competitors to see if a test could be developed to screen for Zika.
The cobas Zika test was approved under an investigational new drug application on March 30, 2016, and although initially used to test blood samples in Puerto Rico, testing was expanded to include donor blood from all over the country.
Screening was conducted by individual donation testing, with all initial reactive results repeated in duplicate. Supplemental testing was also done, and included an alternative NAT (AltNAT) assay which was considered to be less sensitive than cobas Zika and serology testing for anti-Zika IgM and IgG. A donor confirmed Zika confirmed positive if at least one replicate of the repeat testing by cobas Zika was reactive on index donation or follow-up, reactive by AltNAT on the index donation, or positive for anti-Zika IgM on index or follow-up.
Screening was conducted at 12 testing labs in the United States, and more than 4 million donations were screened and 27 positive donations were confirmed. Overall, that amounted to less than 1 in 100,000.
“For donors in the U.S. with confirmed positive results, and for whom follow-up information is available, 84% of them report recent travel to Zika active areas,” noted Dr. Pate.
For Puerto Rico, 111,842 blood donations were screened and there were 356 confirmed positive results. The incidence is much higher than in United States, and was 1.27% during peak incidence in July 2016.
A third paper (C12-A01C), also reported on testing the blood supply in Singapore, which had reported its first locally transmitted Zika case last August, using the investigational Procleix ZIKV nucleic acid technology (NAT) assay.
The presence of Zika virus in screened blood was also quite low, with an incidence of only 0.0032%. The Procleix ZIKV assay was found to suitable for screening for Zika infection in an asymptomatic population, as it showed good analytical sensitivity and clinical performance.
The Zika virus came to Singapore in May 2016, imported by an individual who had recently traveled to Brazil, said Sally Lam, laboratory director, Blood Services Group, Health Sciences Authority, Singapore.
“Then in August we had 41 confirmed local Zika virus cases,” she said.
In 2016, there were 458 clinical Zika cases reported, with 8 clusters identified. This year, 63 cases have been reported to date, she said.
Mandatory Zika virus screening in donor blood with ID-NAT began after the onset of local outbreaks, and was implemented in January 2017. A total of 126,906 blood donations were screened.
Researchers in Singapore assessed the performance of the Procleix ZIKV NAT assay for universal blood donation screening. They screened all blood that was donated, beginning Oct. 1, 2016, a confirmed case was defined as having Zika RNA by PCR and/or Zika antibodies. Analytical sensitivity was assessed by use of 300 blinded frozen samples containing Zika virus and 25 negative controls. The performance of the Procleix ZIKV assay was also evaluated by use of samples from the local patient population.
Of four confirmed positive cases, only one was available for follow-up. “In the index donation, the viral load was quite high in the plasma but at 10 days, it was reduced to about 400 copies/mL in the plasma,” said Ms. Lam. “The donor did not develop any symptoms.”
The analytical sensitivity for the Procleix ZIKV assay was determined to be 2.1 copies/mL at 50% LOD and 10.0 copies/mL at 95% LOD, and it detected RNA in six out of nine patient samples for an 85.7% agreement with reference material, according to the researchers.
AT AABB17
Denmark reinstates ID NAT screening for blood donations
SAN DIEGO – After funding was discontinued for individual donation (ID) nucleic acid testing (NAT) of blood donations, the risk of transfusion-related infections in Denmark increased. But according to new findings presented here at the American Association of Blood Banks annual meeting, that policy was short lived.
When ID NAT was removed from the screening process, the estimated increase in the risk for transfusion-transmitted HIV went from one in 80 years to one in 18 years; for hepatitis B virus (HBV), it went from one in 34 years to one in 17 years; and for hepatitis C virus (HCV), the risk increased from one in 250 years to one in 8 years.
“Between 2009 and 2016, we had 14 NAT reactive/seronegative cases among the repeat donors, and one was due to an acute hepatitis C infection,” said study author Leen Baudewijn, MD, of Odense (Denmark) University Hospital. “This would have been missed without NAT testing.”
Dr. Baudewijn explained that Denmark has since reversed this new policy. “The Danish government decided not to discontinue NAT because there were almost no savings,” she said during her presentation. “We had the extra costs for anti-HBc [anti-Hepatitis B core] testing for repeat donors, and extra cost due to mandatory NAT testing for plasma for manufacturing medicinal products. So it was not possible to abrogate NAT testing because of contracts with the industry.”
However, she added that “one of the most important reasons was that one of the vendors for NAT screening reduced the price substantially by 45%.”
The majority of industrialized countries have implemented the use of increasingly sensitive assays for screening donated blood, although to date, there is no technology that can guarantee zero-risk blood products. However, the risk for transmission of a viral infection via transfusion is low in Northern Europe.
But after a case of HIV infection linked to a blood transfusion occurred, Denmark mandated ID NAT in 2009 for serologic-based screening assays for HIV, HBV, and HCV. In July 2017, the government changed its policy and discontinued funding for ID NAT screening and, instead, mandated anti-Hepatitis B core screening be added to the serologic screening assays for repeat donors.
In this study, Dr. Baudewijn and her colleagues used an incidence/window model to estimate the residual risk (RR) of transfusion-transmitted viral infections after ID NAT was halted in Denmark. They estimated incidence rates for blood and plasma donations obtained from repeat donors during 2006-2016 based on the number of positive tests after a negative donation. The residual risk was estimated as the incidence rate multiplied by the average window period for HIV, HBV, and HCV, with and without ID NAT testing.
A total of 3.5 million donations were screened during the study’s time period, with donors averaging two blood donations per year. The researchers estimated the RR for each donation with and without ID NAT.
For HIV, the RR without ID NAT was 1/3,647,888 and with ID NAT it was 1/16,436,213; for HBV, those numbers were 1/3,352,628 without and 1/6,806,407 with; and for HCV, 1/1,573,213 without and 1/50,429,289, with.
The overall probability of missing an infectious red blood cell unit was 35/1,000 in a population of 6 million, Dr. Baudewijn noted.
The authors had no relevant financial disclosures
SOURCE: Baudewijn L et al. AABB 2017. Abstract P4-A03A.
SAN DIEGO – After funding was discontinued for individual donation (ID) nucleic acid testing (NAT) of blood donations, the risk of transfusion-related infections in Denmark increased. But according to new findings presented here at the American Association of Blood Banks annual meeting, that policy was short lived.
When ID NAT was removed from the screening process, the estimated increase in the risk for transfusion-transmitted HIV went from one in 80 years to one in 18 years; for hepatitis B virus (HBV), it went from one in 34 years to one in 17 years; and for hepatitis C virus (HCV), the risk increased from one in 250 years to one in 8 years.
“Between 2009 and 2016, we had 14 NAT reactive/seronegative cases among the repeat donors, and one was due to an acute hepatitis C infection,” said study author Leen Baudewijn, MD, of Odense (Denmark) University Hospital. “This would have been missed without NAT testing.”
Dr. Baudewijn explained that Denmark has since reversed this new policy. “The Danish government decided not to discontinue NAT because there were almost no savings,” she said during her presentation. “We had the extra costs for anti-HBc [anti-Hepatitis B core] testing for repeat donors, and extra cost due to mandatory NAT testing for plasma for manufacturing medicinal products. So it was not possible to abrogate NAT testing because of contracts with the industry.”
However, she added that “one of the most important reasons was that one of the vendors for NAT screening reduced the price substantially by 45%.”
The majority of industrialized countries have implemented the use of increasingly sensitive assays for screening donated blood, although to date, there is no technology that can guarantee zero-risk blood products. However, the risk for transmission of a viral infection via transfusion is low in Northern Europe.
But after a case of HIV infection linked to a blood transfusion occurred, Denmark mandated ID NAT in 2009 for serologic-based screening assays for HIV, HBV, and HCV. In July 2017, the government changed its policy and discontinued funding for ID NAT screening and, instead, mandated anti-Hepatitis B core screening be added to the serologic screening assays for repeat donors.
In this study, Dr. Baudewijn and her colleagues used an incidence/window model to estimate the residual risk (RR) of transfusion-transmitted viral infections after ID NAT was halted in Denmark. They estimated incidence rates for blood and plasma donations obtained from repeat donors during 2006-2016 based on the number of positive tests after a negative donation. The residual risk was estimated as the incidence rate multiplied by the average window period for HIV, HBV, and HCV, with and without ID NAT testing.
A total of 3.5 million donations were screened during the study’s time period, with donors averaging two blood donations per year. The researchers estimated the RR for each donation with and without ID NAT.
For HIV, the RR without ID NAT was 1/3,647,888 and with ID NAT it was 1/16,436,213; for HBV, those numbers were 1/3,352,628 without and 1/6,806,407 with; and for HCV, 1/1,573,213 without and 1/50,429,289, with.
The overall probability of missing an infectious red blood cell unit was 35/1,000 in a population of 6 million, Dr. Baudewijn noted.
The authors had no relevant financial disclosures
SOURCE: Baudewijn L et al. AABB 2017. Abstract P4-A03A.
SAN DIEGO – After funding was discontinued for individual donation (ID) nucleic acid testing (NAT) of blood donations, the risk of transfusion-related infections in Denmark increased. But according to new findings presented here at the American Association of Blood Banks annual meeting, that policy was short lived.
When ID NAT was removed from the screening process, the estimated increase in the risk for transfusion-transmitted HIV went from one in 80 years to one in 18 years; for hepatitis B virus (HBV), it went from one in 34 years to one in 17 years; and for hepatitis C virus (HCV), the risk increased from one in 250 years to one in 8 years.
“Between 2009 and 2016, we had 14 NAT reactive/seronegative cases among the repeat donors, and one was due to an acute hepatitis C infection,” said study author Leen Baudewijn, MD, of Odense (Denmark) University Hospital. “This would have been missed without NAT testing.”
Dr. Baudewijn explained that Denmark has since reversed this new policy. “The Danish government decided not to discontinue NAT because there were almost no savings,” she said during her presentation. “We had the extra costs for anti-HBc [anti-Hepatitis B core] testing for repeat donors, and extra cost due to mandatory NAT testing for plasma for manufacturing medicinal products. So it was not possible to abrogate NAT testing because of contracts with the industry.”
However, she added that “one of the most important reasons was that one of the vendors for NAT screening reduced the price substantially by 45%.”
The majority of industrialized countries have implemented the use of increasingly sensitive assays for screening donated blood, although to date, there is no technology that can guarantee zero-risk blood products. However, the risk for transmission of a viral infection via transfusion is low in Northern Europe.
But after a case of HIV infection linked to a blood transfusion occurred, Denmark mandated ID NAT in 2009 for serologic-based screening assays for HIV, HBV, and HCV. In July 2017, the government changed its policy and discontinued funding for ID NAT screening and, instead, mandated anti-Hepatitis B core screening be added to the serologic screening assays for repeat donors.
In this study, Dr. Baudewijn and her colleagues used an incidence/window model to estimate the residual risk (RR) of transfusion-transmitted viral infections after ID NAT was halted in Denmark. They estimated incidence rates for blood and plasma donations obtained from repeat donors during 2006-2016 based on the number of positive tests after a negative donation. The residual risk was estimated as the incidence rate multiplied by the average window period for HIV, HBV, and HCV, with and without ID NAT testing.
A total of 3.5 million donations were screened during the study’s time period, with donors averaging two blood donations per year. The researchers estimated the RR for each donation with and without ID NAT.
For HIV, the RR without ID NAT was 1/3,647,888 and with ID NAT it was 1/16,436,213; for HBV, those numbers were 1/3,352,628 without and 1/6,806,407 with; and for HCV, 1/1,573,213 without and 1/50,429,289, with.
The overall probability of missing an infectious red blood cell unit was 35/1,000 in a population of 6 million, Dr. Baudewijn noted.
The authors had no relevant financial disclosures
SOURCE: Baudewijn L et al. AABB 2017. Abstract P4-A03A.
AT AABB17
Key clinical point:
Major finding: Without ID NAT, the estimated increase in the risk for transfusion-transmitted HIV went from 1 patient per 80 years to 1 per 18; for HBV, from 1 per 34 to 1 per 17; and for HCV, the risk increased from 1 per 250 to 1 per 8.
Data source: An incidence/window model estimating the residual risk of transfusion-transmitted viral infections following Denmark’s decision not to fund ID NAT testing.
Disclosures: The authors had no relevant financial disclosures.
SOURCE: Baudewijn L et al. AABB 2017. Abstract P4-A03A.
Lung injury risk higher with apheresis blood products
SAN DIEGO – , according to research presented at the annual meeting of the American Association of Blood Banks.
Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.
“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.
ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.
Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”
In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.
For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.
After 24 hours, the production of IL-8 and IL-6 was measured.
Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.
Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.
Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).
The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.
Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).
However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.
“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”
Dr. Wirtz had no disclosures.
SAN DIEGO – , according to research presented at the annual meeting of the American Association of Blood Banks.
Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.
“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.
ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.
Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”
In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.
For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.
After 24 hours, the production of IL-8 and IL-6 was measured.
Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.
Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.
Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).
The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.
Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).
However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.
“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”
Dr. Wirtz had no disclosures.
SAN DIEGO – , according to research presented at the annual meeting of the American Association of Blood Banks.
Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.
“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.
ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.
Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”
In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.
For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.
After 24 hours, the production of IL-8 and IL-6 was measured.
Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.
Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.
Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).
The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.
Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).
However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.
“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”
Dr. Wirtz had no disclosures.
From AABB17
Key clinical point: The method of manufacturing blood products can markedly influence the interaction of RBC products with lung cells, especially in patients on mechanical ventilation.
Major finding: Apheresis-derived products are the most consistent in causing injuries, while red cell–filtered products appear to be the safest in avoiding lung injury.
Data source: An experimental study that investigated different manufacturing methods of RBC products and the response of pulmonary cells in an in vitro model of mechanical ventilation.
Disclosures: Dr. Wirtz had no disclosures.
Cold stored platelets control bleeding after complex cardiac surgery
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
AT AABB17
Key clinical point: Cold stored leukoreduced apheresis platelets in platelet additive solution are effective for treating bleeding in patients undergoing complex cardiothoracic surgery.
Major finding: Patients who underwent procedures requiring cardiopulmonary bypass circulation had a significantly lower median amount of bleeding in the postoperative period with cold stored platelets compared with standard room temperature platelets: 576 mL vs. 838 mL.
Data source: Randomized two-arm pilot trial of cardiothoracic surgery patients.
Disclosures: The authors have no relevant financial disclosures.
Citrate reactions seen in 7% of apheresis donations
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
AT AABB17
Key clinical point: Adverse reactions to apheresis donations can be significant; calcium supplements can reduce the risk of citrate reactions and volume replacement can reduce the risk of vasovagal reactions in donors.
Major finding: Citrate reactions accompanied 6.8% of donations; 2.5% had vasovagal reactions without loss of consciousness and 0.1% had loss of consciousness.
Data source: A study at Héma-Québec, Montreal, of 80,409 apheresis procedures conducted in 14,742 donors.
Disclosures: Dr. Robillard had no disclosures.
State regulations for tattoo facilities increased blood donor pools
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
AT AABB 2017
Key clinical point:
Major finding: The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
Data source: An analysis of blood centers in California and Arizona before and after state tattoo regulations were implemented.
Disclosures: Dr. Townsend has no disclosures.
Still too early to determine impact of 1-year deferral for MSM blood donors
SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.
In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.
In their study, Dr. Custer and his colleagues assessed the impact of the change in policy on donors and whether there was any early evidence of a change in risk to blood recipients.
At their center, the 1-year deferral was implemented on Aug. 29, 2016. On the health questionnaire that potential donors must complete, males are now asked two questions – one regarding sexual contact with men in the previous 12 months, and another about sex with men since 1977.
The rates of deferral were evaluated in two 7-month periods before and after the policy change (September 2015-March 2016 and September 2016-March 2017). They also looked at donor requests to be reinstated in lieu of the new policy, along with infectious disease marker test results in accepted donors.
In 272,306 interviews conducted before the policy change, 408 men responded yes to having sex with men since 1977 and 370 were deferred.
For the 252,395 interviews conducted after the policy change, 245 men answered yes to having sexual contact with men in the previous 12 months, and 245 were deferred.
Some of the men who reported having sex with men before the policy change were evaluated and accepted as donors. Overall, the donor acceptance rate was 9.3% during the period before the policy change, and 64.2% for the period after the policy change.
“Only 67 men requested to be reinstated and have been reinstated, and 39 returned to donate. There have been 59 successful donations to date,” said Dr. Custer.
Some of the reinstated donors were deferred for reasons similar to those for deferral of donors who are not men who have sex with men. Although it is still too early to draw any conclusions, Dr. Custer noted that they are being cautious, because infectious markers still are running a little higher among male donors with a history of having sex with men and donors without such a history.
SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.
In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.
In their study, Dr. Custer and his colleagues assessed the impact of the change in policy on donors and whether there was any early evidence of a change in risk to blood recipients.
At their center, the 1-year deferral was implemented on Aug. 29, 2016. On the health questionnaire that potential donors must complete, males are now asked two questions – one regarding sexual contact with men in the previous 12 months, and another about sex with men since 1977.
The rates of deferral were evaluated in two 7-month periods before and after the policy change (September 2015-March 2016 and September 2016-March 2017). They also looked at donor requests to be reinstated in lieu of the new policy, along with infectious disease marker test results in accepted donors.
In 272,306 interviews conducted before the policy change, 408 men responded yes to having sex with men since 1977 and 370 were deferred.
For the 252,395 interviews conducted after the policy change, 245 men answered yes to having sexual contact with men in the previous 12 months, and 245 were deferred.
Some of the men who reported having sex with men before the policy change were evaluated and accepted as donors. Overall, the donor acceptance rate was 9.3% during the period before the policy change, and 64.2% for the period after the policy change.
“Only 67 men requested to be reinstated and have been reinstated, and 39 returned to donate. There have been 59 successful donations to date,” said Dr. Custer.
Some of the reinstated donors were deferred for reasons similar to those for deferral of donors who are not men who have sex with men. Although it is still too early to draw any conclusions, Dr. Custer noted that they are being cautious, because infectious markers still are running a little higher among male donors with a history of having sex with men and donors without such a history.
SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.
In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.
In their study, Dr. Custer and his colleagues assessed the impact of the change in policy on donors and whether there was any early evidence of a change in risk to blood recipients.
At their center, the 1-year deferral was implemented on Aug. 29, 2016. On the health questionnaire that potential donors must complete, males are now asked two questions – one regarding sexual contact with men in the previous 12 months, and another about sex with men since 1977.
The rates of deferral were evaluated in two 7-month periods before and after the policy change (September 2015-March 2016 and September 2016-March 2017). They also looked at donor requests to be reinstated in lieu of the new policy, along with infectious disease marker test results in accepted donors.
In 272,306 interviews conducted before the policy change, 408 men responded yes to having sex with men since 1977 and 370 were deferred.
For the 252,395 interviews conducted after the policy change, 245 men answered yes to having sexual contact with men in the previous 12 months, and 245 were deferred.
Some of the men who reported having sex with men before the policy change were evaluated and accepted as donors. Overall, the donor acceptance rate was 9.3% during the period before the policy change, and 64.2% for the period after the policy change.
“Only 67 men requested to be reinstated and have been reinstated, and 39 returned to donate. There have been 59 successful donations to date,” said Dr. Custer.
Some of the reinstated donors were deferred for reasons similar to those for deferral of donors who are not men who have sex with men. Although it is still too early to draw any conclusions, Dr. Custer noted that they are being cautious, because infectious markers still are running a little higher among male donors with a history of having sex with men and donors without such a history.
AT AABB2017
Key clinical point:
Major finding: Of 370 men deferred for blood donation because of ever having sex with a man since 1977, 67 have requested to be reinstated as donors under the new 1-year deferral policy and 39 returned to donate blood.
Data source: 272,306 interviews conducted before the policy change, and 252,395 interviews conducted after the policy change, at Blood Systems Research Institute.
Disclosures: Dr. Custer had no relevant financial disclosures.
Measures needed to identify past pregnancy in transgender male blood donors
SAN DIEGO –
In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.
Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.
For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.
The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.
Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.
Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.
From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.
After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.
“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.
Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.
“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”
But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”
Dr. Grima had no financial disclosures.
SAN DIEGO –
In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.
Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.
For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.
The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.
Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.
Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.
From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.
After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.
“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.
Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.
“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”
But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”
Dr. Grima had no financial disclosures.
SAN DIEGO –
In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.
Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.
For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.
The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.
Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.
Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.
From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.
After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.
“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.
Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.
“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”
But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”
Dr. Grima had no financial disclosures.
AT AABB17
Key clinical point: First-time transgender male donors with a history of pregnancy will not be identified, and HLA testing might not be performed unless these donors volunteer this information.
Major finding: Among 447 transgender males who were identified, 3% had been pregnant, and 1% tested positive for HLA antibodies.
Data source: A review of data from the blood bank at the Brooklyn Hospital Center, New York.
Disclosures: Dr. Grima had no financial disclosures.