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New Device Speeds Coagulation Test Results

SAN DIEGO – A device recently approved in the United States could greatly speed decisions about transfusion and coagulation management in patients undergoing noncardiac surgery or liver transplantation, according to Dr. Klaus Görlinger.

Conventional coagulation tests can take 20-30 minutes to produce results, he said at the annual meeting of the American Society of Anesthesiologists. "This is too long for us to make our decisions," said Dr. Görlinger of University Hospital, Essen, Germany.

Photo credit: Tem Innovations GmbH
    The ROTEM rotational thromboelastometry device can complete coagulation tests in just 12-15 minutes.

He and his associates retrospectively analyzed data on 866 patients who underwent liver transplantation, visceral surgery, trauma surgery, or neurosurgery that included blood analysis using the ROTEM rotational thromboelastometry device. They looked at whether maximum clot firmness could be predicted by the amplitude of clot firmness at 5, 10, or 15 minutes after clotting time or by clot formation time, to shorten time to treatment when necessary.

The amplitude of clot firmness at 10 minutes after clotting time showed excellent correlation with maximum clot firmness and was superior to using clot formation time. "So, 12-15 minutes after starting the test, we can make our decisions about what to do in our patients," he said.

A comparison of results using various assays with the ROTEM showed that the extrinsically activated test produced useful results slightly faster than did the intrinsically activated test, which takes a bit longer to start. Both showed excellent correlation with maximum clot firmness and were superior to using clot formation time.

The Food and Drug Administration cleared the ROTEM for use in early 2010, but "only the intrinsically activated tests are FDA approved. We hope all of them will be soon," commented Dr. Linda Shore-Lesserson, comoderator of the session at the meeting. "This is really useful, not having to wait 20-25 minutes for information," said Dr. Shore-Lesserson of Montefiore Medical Center, New York.

And in situations requiring even faster decisions on transfusion and coagulation management, the 5-minute amplitude of clot firmness also provides good predictive value for the maximum clot firmness, "so we can start our specific intervention 10-12 minutes after blood sampling," Dr. Görlinger added.

At his facility, eight ROTEM devices are used in operating rooms, one in the liver transplant ICU, and one in the cardiac ICU. "We can take the device on small trolleys with us to the OR. We have four channels [on the device] and different tests we can use to differentiate what kind of problem we have in our patients," he said.

Dr. Stanley Brauer, another speaker at the session, said he was impressed by Dr. Görlinger’s findings. "After seeing your presentation, I plan to go back to my hospital administrators and ask them to order the ROTEM," said Dr. Brauer, professor of anesthesiology, Loma Linda (Calif.) University.

The study excluded ROTEM analyses that had a run time shorter than 35 minutes and perhaps hadn’t reached a maximum amplitude of clot firmness, Dr. Görlinger said. The study also excluded patients with signs of hyperfibrinolysis. It included patients regardless of whether they had been treated prior to ROTEM analysis of their blood.

Dr. Görlinger said he has received consulting fees and honoraria from Tem Innovations GmbH, which makes the ROTEM device, and CSL Behring GmbH. Two of his coinvestigators have received speaking fees from CSL Behring.

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SAN DIEGO – A device recently approved in the United States could greatly speed decisions about transfusion and coagulation management in patients undergoing noncardiac surgery or liver transplantation, according to Dr. Klaus Görlinger.

Conventional coagulation tests can take 20-30 minutes to produce results, he said at the annual meeting of the American Society of Anesthesiologists. "This is too long for us to make our decisions," said Dr. Görlinger of University Hospital, Essen, Germany.

Photo credit: Tem Innovations GmbH
    The ROTEM rotational thromboelastometry device can complete coagulation tests in just 12-15 minutes.

He and his associates retrospectively analyzed data on 866 patients who underwent liver transplantation, visceral surgery, trauma surgery, or neurosurgery that included blood analysis using the ROTEM rotational thromboelastometry device. They looked at whether maximum clot firmness could be predicted by the amplitude of clot firmness at 5, 10, or 15 minutes after clotting time or by clot formation time, to shorten time to treatment when necessary.

The amplitude of clot firmness at 10 minutes after clotting time showed excellent correlation with maximum clot firmness and was superior to using clot formation time. "So, 12-15 minutes after starting the test, we can make our decisions about what to do in our patients," he said.

A comparison of results using various assays with the ROTEM showed that the extrinsically activated test produced useful results slightly faster than did the intrinsically activated test, which takes a bit longer to start. Both showed excellent correlation with maximum clot firmness and were superior to using clot formation time.

The Food and Drug Administration cleared the ROTEM for use in early 2010, but "only the intrinsically activated tests are FDA approved. We hope all of them will be soon," commented Dr. Linda Shore-Lesserson, comoderator of the session at the meeting. "This is really useful, not having to wait 20-25 minutes for information," said Dr. Shore-Lesserson of Montefiore Medical Center, New York.

And in situations requiring even faster decisions on transfusion and coagulation management, the 5-minute amplitude of clot firmness also provides good predictive value for the maximum clot firmness, "so we can start our specific intervention 10-12 minutes after blood sampling," Dr. Görlinger added.

At his facility, eight ROTEM devices are used in operating rooms, one in the liver transplant ICU, and one in the cardiac ICU. "We can take the device on small trolleys with us to the OR. We have four channels [on the device] and different tests we can use to differentiate what kind of problem we have in our patients," he said.

Dr. Stanley Brauer, another speaker at the session, said he was impressed by Dr. Görlinger’s findings. "After seeing your presentation, I plan to go back to my hospital administrators and ask them to order the ROTEM," said Dr. Brauer, professor of anesthesiology, Loma Linda (Calif.) University.

The study excluded ROTEM analyses that had a run time shorter than 35 minutes and perhaps hadn’t reached a maximum amplitude of clot firmness, Dr. Görlinger said. The study also excluded patients with signs of hyperfibrinolysis. It included patients regardless of whether they had been treated prior to ROTEM analysis of their blood.

Dr. Görlinger said he has received consulting fees and honoraria from Tem Innovations GmbH, which makes the ROTEM device, and CSL Behring GmbH. Two of his coinvestigators have received speaking fees from CSL Behring.

SAN DIEGO – A device recently approved in the United States could greatly speed decisions about transfusion and coagulation management in patients undergoing noncardiac surgery or liver transplantation, according to Dr. Klaus Görlinger.

Conventional coagulation tests can take 20-30 minutes to produce results, he said at the annual meeting of the American Society of Anesthesiologists. "This is too long for us to make our decisions," said Dr. Görlinger of University Hospital, Essen, Germany.

Photo credit: Tem Innovations GmbH
    The ROTEM rotational thromboelastometry device can complete coagulation tests in just 12-15 minutes.

He and his associates retrospectively analyzed data on 866 patients who underwent liver transplantation, visceral surgery, trauma surgery, or neurosurgery that included blood analysis using the ROTEM rotational thromboelastometry device. They looked at whether maximum clot firmness could be predicted by the amplitude of clot firmness at 5, 10, or 15 minutes after clotting time or by clot formation time, to shorten time to treatment when necessary.

The amplitude of clot firmness at 10 minutes after clotting time showed excellent correlation with maximum clot firmness and was superior to using clot formation time. "So, 12-15 minutes after starting the test, we can make our decisions about what to do in our patients," he said.

A comparison of results using various assays with the ROTEM showed that the extrinsically activated test produced useful results slightly faster than did the intrinsically activated test, which takes a bit longer to start. Both showed excellent correlation with maximum clot firmness and were superior to using clot formation time.

The Food and Drug Administration cleared the ROTEM for use in early 2010, but "only the intrinsically activated tests are FDA approved. We hope all of them will be soon," commented Dr. Linda Shore-Lesserson, comoderator of the session at the meeting. "This is really useful, not having to wait 20-25 minutes for information," said Dr. Shore-Lesserson of Montefiore Medical Center, New York.

And in situations requiring even faster decisions on transfusion and coagulation management, the 5-minute amplitude of clot firmness also provides good predictive value for the maximum clot firmness, "so we can start our specific intervention 10-12 minutes after blood sampling," Dr. Görlinger added.

At his facility, eight ROTEM devices are used in operating rooms, one in the liver transplant ICU, and one in the cardiac ICU. "We can take the device on small trolleys with us to the OR. We have four channels [on the device] and different tests we can use to differentiate what kind of problem we have in our patients," he said.

Dr. Stanley Brauer, another speaker at the session, said he was impressed by Dr. Görlinger’s findings. "After seeing your presentation, I plan to go back to my hospital administrators and ask them to order the ROTEM," said Dr. Brauer, professor of anesthesiology, Loma Linda (Calif.) University.

The study excluded ROTEM analyses that had a run time shorter than 35 minutes and perhaps hadn’t reached a maximum amplitude of clot firmness, Dr. Görlinger said. The study also excluded patients with signs of hyperfibrinolysis. It included patients regardless of whether they had been treated prior to ROTEM analysis of their blood.

Dr. Görlinger said he has received consulting fees and honoraria from Tem Innovations GmbH, which makes the ROTEM device, and CSL Behring GmbH. Two of his coinvestigators have received speaking fees from CSL Behring.

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FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS

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Major Finding: The amplitude of clot firmness 10 minutes after clotting time reported by a rotational thromboelastometry device correlated highly with maximum clot firmness, which could speed management decisions.

Data Source: Retrospective analysis of data from 866 patients undergoing liver transplantation or noncardiac surgery whose blood was analyzed by ROTEM.

Disclosures: Dr. Görlinger said he has received consulting fees and honoraria from Tem Innovations GmbH, which makes the ROTEM device, and CSL Behring GmbH. Two of his coinvestigators have received speaking fees from CSL Behring.