A Comparison of Hemostatic Effectiveness and Safety of Two FibrinSealant Patch Products after Severe Renal Hemorrhage in Swine Model ofDilutional and Hypothermic Coagulopathy

Background: Two fibrin sealant patch products (EVARREST™ and TachoSil™) are approved by the USFDA for use in surgical settings. While these products are among the most likely to be useful for trauma use, they are not approved for this use. There is a clinical need for trauma hemostats. Methods: A well characterized animal model for severe soft tissue hemorrhage (partial nephrectomy) was combined with another well characterized model for dilutional and hypothermic coagulopathy. The two fibrin sealant patch materials available in the US were each applied to 12 animals. Animal assignment was randomized. If hemostasis could be achieved, the animals were resuscitated and survived for 48 hours. Results: TachoSil™ was able to achieve hemostasis in 2 of 12 animals which survived to the scheduled necropsy date without significant pathology. For the two successful animals, the mean time to achieve hemostasis was 6.5 (+/-2.12) minutes, and 178.00 (+/-79.22) grams of blood were lost before hemostasis was achieved. EVARREST™ was able to achieve hemostasis in all 12 animals, and all animals survived to the scheduled necropsy date without significant pathology. The mean time to achieve hemostasis was 3.5 (+/-1.45) minutes, and 52.11 (+/-18.92) grams of blood were lost prior to achieving hemostasis. Conclusions: When fibrin sealant patch products can achieve intraoperative hemostasis, animals can be resuscitated and survive without significant pathology. The two available products vary considerably in intraoperative efficacy.