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In the study, the proportion of patients achieving hemostasis at 10minutes (primary outcome) was 97.4% following treatment with human thrombinand also following treatment with bovine-derived thrombin. The percentages ofpatients achieving hemostasis at six minutes and three minutes were alsoequivalent. There were no statistically significant differences in severalother variables including laboratory assessments, vital signs, blood loss,blood transfusions, time in specialty-care unit, procedure duration, andlength of hospital stay.
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On August 27, the U.S. FDA approved EVITHROM* Thrombin, Topical (Human)for use in cardiovascular, neurological and general surgery. EVITHROM* wasdeveloped in collaboration with OMRIX Biopharmaceuticals, Inc. ETHICON plansto make the product commercially available in the United States in Q4 2007.
"With EVITHROM*, the first plasma-derived human thrombin, surgeons have anew option for hemostasis that is as effective as bovine-derived thrombin butthat also reduces the risks of antibody formation associated with the use ofthrombin derived from bovine sources," said Cataldo Doria, M.D., ThomasJefferson University Hospital. Dr. Doria was lead author of the study.
According to the study results, plasma-derived human thrombin and bovinethrombin have similar adverse event profiles. However, more patients whoreceived bovine thrombin demonstrated seroconversion for at least one of thefour 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 SABMmeeting. This study compared the safety and effectiveness of EVICEL* FibrinSealant (Human), which contains the same human thrombin as in EVITHROM*, tomanual compression (MC) in achieving hemostasis in vascular surgery. In thestudy, a higher percentage of patients who received EVICEL* achievedhemostasis at four-, seven- and 10-minute time points than patients whoreceived MC. In addition, a lower incidence of treatment failures was observedin the fibrin sealant group. The results of this study suggest that EVICEL* isuseful for achieving rapid hemostasis for indicated procedures whileintroducing no new safety concerns. EVICEL* consists of human plasma-derivedthrombin and fibrinogen and is currently the only aprotinin-free fibrinsealant commercially available in the U.S.
EVITHROM* and EVICEL* are contraindicated in individuals known to haveanaphylactic or severe systemic reaction to human blood products. As with allplasma-derived products, the risk of transmitting infectious agents cannot becompletely eliminated. EVITHROM* and EVICEL* should not be injected directlyinto the circulatory system or used for the treatment of severe or briskarterial bleeding. There is a potential risk of thrombosis if EVITHROM* isabsorbed systemically.
About ETHICON, Inc.
ETHICON, Inc., a Johnson & Johnson company, is a global medical devicecompany that develops and markets surgical products for use in generalsurgery, wound management and women's health & urology. Johnson & JohnsonWound Management, a division of ETHICON, offers a complete portfolio oftopical and advanced hemostatic products in
