Safety and efficacy of thrombin-JMI: a multidisciplinary expert group consensus.
(Journal Article;Multicenter Study)
BACKGROUND: The use of bovine thrombin has been an effective approach to aiding hemostasis during surgery for over 60 years. Its use has a reported association with the development of antibodies to coagulation factors with limited evidence to the clinical significance. METHODS: The Collaborative Delphi survey methodology was used to develop a consensus on specified topic areas from a panel of 12 surgeons/scientists who have had experience with topical thrombins; it consisted of 2 rounds of a Web-based survey and a final live discussion. RESULTS: Some key issues that reached consensus included: bovine, human plasma-derived and recombinant human thrombin are equally effective hemostatic agents with similar adverse event rates, and immunogenicity to a topical protein rarely translate into adverse events. CONCLUSIONS: Although a risk of immunogenicity is associated with all topical thrombins, no conclusive clinical evidence is available that these antibodies have any significant effect on short- and long-term clinical consequences.
Bhandari, M; Ofosu, FA; Mackman, N; Jackson, C; Doria, C; Humphries, JE; Babu, SC; Ortel, TL; Hoffman Van Thiel, D; Walenga, JM; Wahi, R; Teoh, KHT; Fareed, J
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