A Novel Biologic Hemostatic Dressing (Fibrin Patch) Reduces Blood Loss and Resuscitation Volume and Improves Survival in Hypothermic, Coagulopathic Swine With Grade V Liver Injury

Abstract

This study evaluated the efficacy of a biologic hemostatic fibrin patch (FP) to control coagulopathic bleeding and prevent death in a porcine model of severe liver injury with hemodilution and hypothermia. Coagulopathy was produced in swine by exchanging 60% of the animals' circulating blood volume with Hextend and lowering the core temperature to 32.0 degrees C +/- 0.5 degrees C. A grade V liver injury was induced and allowed to bleed freely for 30 seconds (pretreatment blood loss). Animals were randomly divided into three treatment groups: hepatic packing (HP) using laparotomy sponges, FP application plus HP, or placebo patch (PP) application plus HP. Animals were resuscitated to 80% of the preinjury mean arterial pressure. Core temperature, mean arterial pressure, and survival were monitored for 1 hour postinjury. Packs were removed from the animals that survived to 1 hour and they were monitored for an additional hour. Coagulopathy was confirmed by significant increases (p < 0.01) in prothrombin time, activated partial thromboplastin time, and activated clotting time in preinjury measurements as compared with baseline values. Pretreatment blood loss was not different among the groups. However, significant (p < 0.01) differences were observed in the posttreatment blood loss (772 mL +/- 340 mL, 4,977 mL +/- 440 mL, 4,173 mL +/- 608 mL), as well as the required fluid resuscitation volume (994 mL +/- 26 mL, 4,083 mL +/- 185 mL, 3,494 mL +/- 492 mL), between FP versus PP or HP groups, respectively. In addition, 89% of FP animals survived the 2-hour observation with an average survival time of 111 minutes +/- 9 minutes, which was significantly higher than the PP (0% survival, 39 minutes +/- 4 minutes) or HP (13% survival, 41 minutes +/- 12 minutes) groups. FP with packing effectively controlled coagulopathic bleeding and prevented death in a model of grade V liver injury in which HP alone (standard of care) was ineffective.