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New study shows promise in reducing surgical risks associated with surgical bleeding

CHICAGO (August 10, 2007) Surgeons may have a new patient safety tool to stop moderate surgical bleeding without some of the concerns associated with the current standard blood-clotting treatment. New research published in the August issue of the Journal of the American College of Surgeons shows that recombinant human thrombin (rhThrombin) reduces the risk of surgical complications associated with the use of plasma-derived bovine thrombin (bThrombin), which is currently the only commercially available stand-alone thrombin used to improve clotting during surgical procedures and stop bleeding.

Each year, bThrombin is used to treat more than one million patients who undergo surgical procedures in the United States. However, approximately 20 percent of these patients develop antibodies against bovine coagulation factors that can cross-react with human coagulation proteins and possibly lead to adverse effects, including severe bleeding and thrombosis. Due to these safety concerns, rhThrombin was developed as an alternative to bThrombin.

We constantly look for new ways to reduce risks in surgery and stopping surgical bleeding safely and effectively is of foremost interest to surgeons. The results from this phase III trial show that we can stop bleeding in 95 percent of patients within 10 minutes and do so without introducing foreign proteins that can carry greater risk of development of antibodies, said William C. Chapman, MD, FACS, Department of Surgery, Washington University, St. Louis (MO) School of Medicine. Im most encouraged by the increasing evidence that recombinant technology is safe and effective because it means that we may be able to avoid using blood or blood products from other people or animals and automatically diminish the risk of infection and the associated immunologic responses that have been noted in the past.

The randomized, double-blind comparative study included 411 patients who underwent surgical procedures at
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Contact: Sally Garneski
pressinquiry@facs.org
312-202-5409
Weber Shandwick Worldwide
10-Aug-2007


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