Safety and Efficacy of Thrombin-JMI: A Multidisciplinary Expert Group Consensus Academic Article uri icon

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abstract

  • 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.

authors

  • Bhandari, Mohit
  • Ofosu, Frederick A
  • Mackman, Nigel
  • Jackson, Craig
  • Doria, Cataldo
  • Humphries, John E
  • Babu, Sateesh C
  • Ortel, Thomas L
  • Hoffman Van Thiel, David
  • Walenga, Jeanine M
  • Wahi, Rakesh
  • Teoh, Kevin Hong To
  • Fareed, Jawed

publication date

  • February 2011