Evaluation of a novel hemostatic device in an ovine parenchymal organ bleeding model of normal and impaired hemostasis

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Abstract
Bleeding is a problem encountered by many surgeons, often complicated by the presence of coagulopathy or anticoagulant. The hemostatic effectiveness of CoStasis® Surgical Hemostat (with bovine collagen, bovine thrombin, and autologous plasma) was evaluated and compared to a collagen sponge and to two investigational fibrin‐sealant preparations under conditions of normal and impaired coagulation. A liver resection and controlled incisions in spleens and kidneys were made in sheep. Time to complete hemostasis and total blood loss were measured. Tissue response was evaluated at 7, 30, 60, and 75 days. CoStasis®‐treated sites demonstrated significantly shorter time to hemostasis (all surgical sites combined) compared with fibrin sealant (investigational fibrin sealant 1) (p=.005) or collagen sponge (p=0.013). In anticoagulated animals, CoStasis® and fibrin sealant (investigational fibrin sealant 2) had comparable mean times to hemostasis, and CoStasis®‐treated sites exhibited lowered average blood loss compared to investigational fibrin‐sealant‐2 treated sites. CoStasis®‐treated sites demonstrated higher levels of tissue repair (lower inflammation, more extensive tissue repair, and less residual implant) compared to fibrin–sealant‐ or collagen–sponge‐treated sites in Phases I and II. These findings demonstrate that CoStasis® is a highly effective hemostatic agent for control of bleeding from parenchymal organs. Furthermore, under conditions of compromised coagulation, treatment with CoStasis® demonstrates a reduction in average blood loss when compared to treatment with fibrin sealant. © 2001 Wiley Periodicals, Inc. J Biomed Mater Res (Appl Biomater) 63: 37–47, 2002