Topical Recombinant Human Thrombin in Surgical Hemostasis

ABSTRACT

The achievement of hemostasis is paramount, and good operative practice is crucial to all surgical procedures. Intraoperative hemostasis is usually achieved through suture ligation for larger vessels and electrocautery of smaller vessels; certain cases, however, are not amenable to these techniques, especially when there is diffuse raw surface bleeding. When operative hemorrhage exists despite appropriate preventive actions and good surgical technique, additional methods for controlling intra- and perioperative hemorrhage should be considered, and may include the use of topical thrombin. Recombinant human thrombin (rhThrombin) was approved by the Food and Drug Administration in 2008, with the expectation of overcoming the disadvantages of previously available topical thrombin preparations. The efficacy of rhThrombin has been demonstrated in three randomized controlled trials and found to be effective for achieving hemostasis within 10 minutes of administration for mild to moderate diffuse raw surface bleeding. rhThrombin is equally as effective as bovine thrombin, with a significantly lower risk of immunogenicity. Similar economic parameters, efficacy, and safety profiles between rhThrombin and other available thrombin preparations may support its use over other bovine- and plasma-derived human thrombin products and carry limited to no risk of viral transmission or development of antithrombin antibodies.

KEYWORDS

Topical - recombinant thrombin - hemostasis - antithrombin antibodies - thrombin

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