Recent developments in topical thrombins

Craig M. Kessler; Thomas L. Ortel

doi:10.1160/TH09-01-0034

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2009; 102(01): 15-24
DOI: 10.1160/TH09-01-0034

Review Article

Schattauer GmbH

Recent developments in topical thrombins

Craig M. Kessler

¹Division of Coagulation, Department of Laboratory Medicine, Georgetown University, Washington, DC, USA

,

Thomas L. Ortel

²Hemostasis and Thrombosis Center, Duke University, Durham, North Carolina, USA

› Author Affiliations

Abstract

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 black-box 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.

Keywords

Bovine - coagulopathy - haemostasis - recombinant - thrombin

Full Text

References

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