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Recent developments in topical thrombins

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH09-01-0034
Issue: 2009: 102/1 (July) pp. 1-183
Pages: 15-24

Recent developments in topical thrombins

Craig M. Kessler 1; Thomas L. Ortel2
1 Division of Coagulation, Department of Laboratory Medicine, Georgetown University, Washington, DC, USA; 2 Hemostasis and Thrombosis Center, Duke University, Durham, North Carolina, USA

Keywords

thrombin, Haemostasis, coagulopathy, Bovine, Recombinant

Summary

Managing blood loss is part of the surgeon’s responsibility during surgical procedures, and a variety of therapeutic strategies are available to help accomplish this. Topical haemostatic agents are among the agents used to control surgical bleeding and locally arrest blood flow. Bovine thrombin is a commonly used topical haemostatic agent; however, its use has been associated with potential risks, including well-documented cases of antibodymediated coagulopathy. This coagulopathy develops as a consequence of antibody formation directed against bovine thrombin, other bovine coagulation proteins, and their human orthologs. The fact that a coagulopathy can result in association with the use of bovine plasma-derived thrombin preparations prompted the FDA to require pharmaceutical companies to place a blackbox warning in their prescribing information for products containing bovine plasma-derived thrombin. Recently, human plasma- derived thrombin and recombinant human thrombin have been approved by the FDA with the expectation that they will be less immunogenic than the bovine-derived product. In clinical studies, purified human plasma-derived thrombin and recombinant thrombin have demonstrated equivalent efficacy and safety, with improved immunogenicity profiles compared with bovinederived thrombin agents. Well-designed and adequately powered clinical trials should be conducted to indicate whether human thrombin products would improve the risk-benefit and costbenefit profiles for surgeries complicated by excessive bleeding.

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