Study Shows Plasma-Derived Human Thrombin Equivalent to Bovine Thrombin in Achieving Hemostasis ...( Results presented at the 6th Ann...),Health

Results presented at the 6th Annual Meeting of the Society for the

Advancement of Blood Management (SABM). Separate study presented at SABM finds EVICEL* Fibrin Sealant (Human) more effective than manual compression in achieving hemostasis in vascular

surgery.

SOMERVILLE, N.J., Sept. 11 /PRNewswire/ -- A randomized study comparing treatment with plasma-derived human thrombin and thrombin derived from bovine sources shows that human thrombin is as effective as bovine thrombin in achieving hemostasis in patients at three-, six- and 10-minute intervals. The study of 305 patients with mild or moderate bleeding during elective cardiovascular, neurological or general surgical procedures also showed that human thrombin was less likely to result in an immune response in patients as compared to bovine thrombin. Study results were presented Friday at the Society for the Advancement of Blood Management meeting in Los Angeles. The study was supported by ETHICON, Inc.

In the study, the proportion of patients achieving hemostasis at 10 minutes (primary outcome) was 97.4% following treatment with human thrombin and also following treatment with bovine-derived thrombin. The percentages of patients achieving hemostasis at six minutes and three minutes were also equivalent. There were no statistically significant differences in several other variables including laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care unit, procedure duration, and length of hospital stay.

On August 27, the U.S. FDA approved EVITHROM* Thrombin, Topical (Human) for use in cardiovascular, neurological and general surgery. EVITHROM* was developed in collaboration with OMRIX Biopharmaceuticals, Inc. ETHICON plans to make the product commercially available in the United States in Q4 2007.

"With EVITHROM*, the first plasma-derived human thrombin, surgeons have a new option for hemos
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