Objective: In this study, we investigated the efficacy of a fibrinogen/thrombin-coated collagen patch (TachoSil) to terminate severe bleeding in a coagulopathic pig model with blunt liver injury.
Methods: Following surgical preparation, which included splenectomy and cystotomy, coagulopathy was induced by exchanging 80% of the animal's blood volume with hydroxyethylstarch 130/0.4 and lactated Ringer's solution. Subsequently, a grade III liver injury was induced by a force of 238 ± 19 Newton and free bleeding was allowed for 30 s. Animals were randomly assigned to receive either a placebo patch (cotton patch) (control group, n = 7) or a fibrinogen/thrombin patch (FT patch group, n = 7), which was positioned 30 s after injury on the inflicted area. Coagulation parameters, hemodynamic variables, as well as treatment were monitored for 2 h post-injury and patch placement. Histology was obtained to evaluate the equality of liver injury and to show the morphology of the FT patch.
Results: Hemostasis after hemodilution was severely impaired. Blood loss after trauma was significantly diminished in the FT patch group (419 mL ± 90 mL) compared with the control group (1775 mL ± 358 mL) (P < 0.001). All animals treated with the FT patch survived, whereas 100% of the control group died before reaching the end of the observation period (P < 0.001). Gross sectioning and histology showed an equal degree of injury with a tight adherence of the FT patch.
Conclusion: TachoSil under severe coagulopathy effectively controlled bleeding and successfully prevented hemorrhagic death.
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