Effect of TachoSil in a coagulopathic pig model with blunt liver injuries.

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.