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Study Shows Plasma-Derived Human Thrombin Equivalent to Bovine Thrombin in Achieving Hemostasis in Surgery
Date:9/11/2007

tasis that is as effective as bovine-derived thrombin but that also reduces the risks of antibody formation associated with the use of thrombin derived from bovine sources," said Cataldo Doria, M.D., Thomas Jefferson University Hospital. Dr. Doria was lead author of the study.

According to the study results, plasma-derived human thrombin and bovine thrombin have similar adverse event profiles. However, more patients who received bovine thrombin demonstrated seroconversion for at least one of the four antibodies assayed than did patients who received human thrombin (12.7% versus 3.3%, respectively).

Results from a separate second study were also presented at the SABM meeting. This study compared the safety and effectiveness of EVICEL* Fibrin Sealant (Human), which contains the same human thrombin as in EVITHROM*, to manual compression (MC) in achieving hemostasis in vascular surgery. In the study, a higher percentage of patients who received EVICEL* achieved hemostasis at four-, seven- and 10-minute time points than patients who received MC. In addition, a lower incidence of treatment failures was observed in the fibrin sealant group. The results of this study suggest that EVICEL* is useful for achieving rapid hemostasis for indicated procedures while introducing no new safety concerns. EVICEL* consists of human plasma-derived thrombin and fibrinogen and is currently the only aprotinin-free fibrin sealant commercially available in the U.S.

EVITHROM* and EVICEL* are contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products. As with all plasma-derived products, the risk of transmitting infectious agents cannot be completely eliminated. EVITHROM* and EVICEL* should not be injected directly into the circulatory system or used for the treatment of severe or brisk arterial bleeding. There is a potential risk of thrombosis if EVITHROM* is absorbed systemically.

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