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

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. 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. 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. TachoSil under severe coagulopathy effectively controlled bleeding and successfully prevented hemorrhagic death.

Grottke O ，Braunschweig T ，Daheim N ，Coburn M ，Grieb G ，Rossaint R ，Tolba R ... -  《-》

Fibrin patch in a pig model with blunt liver injury under severe hypothermia.

Rapid control of hemorrhage is one of the key aspects in trauma handling. To cope with bleeding, local hemostatic approaches are useful, along with surgical and systemic homostatic therapy. In this experimental study, we investigated the efficacy of a fibrinogen/thrombin containing collagen patch (TachoSil) in a coagulopathic pig model with blunt liver trauma under severe hypothermia. Eighteen anesthetized pigs underwent hemodilution by exchanging 70% of the blood volume with Ringer Lactate solution and hydroxyethyl starch 130/0.4 (1:1). Ten minutes after induction of a grade III blunt liver trauma, the animals randomly received treatment with TachoSil (FT-patch, n = 9) or a collagen patch (Tachotop, control group, n = 9). Blood loss, hemodynamics, and coagulation parameters were observed for 2 h. To confirm the consistency of liver trauma, pathologic examination of the liver tissue was performed. Hypothermia (33.5°C ± 0.5°C) and hemodilution led to severe coagulopathy as measured by thromboelastometry and coagulation parameters. After trauma and patch application, thromboelastometry and coagulation parameters in the control group showed further deterioration compared with the stable parameters in the FT-patch group. The total blood loss was significantly reduced in the FT-patch group (FT-patch: 1195 mL; control group: 2495 mL; P < 0.001). Concordantly, the control animals were hemodynamically jeopardized to a higher degree. Microscopy confirmed a similar degree of liver injury. Despite severe hypothermia and coagulopathy, TachoSil provided effective hemorrhage control in pigs with blunt liver injury. Therefore, TachoSil demonstrated usefulness as an additional early therapy in cases of uncontrolled bleeding following severe trauma.

Zentai C ，Braunschweig T ，Rossaint R ，Daniels M ，Czaplik M ，Tolba R ，Grottke O ... -  《-》

Prothrombin complex concentrate reduces blood loss and enhances thrombin generation in a pig model with blunt liver injury under severe hypothermia.

Honickel M ，Rieg A ，Rossaint R ，Braunschweig T ，Spronk HM ，ten Cate H ，van Oerle R ，Tolba R ，Grottke O ... -  《-》

Recombinant factor VIIa reduces bleeding after blunt liver injury in coagulopathic, hypofibrinogenaemic pigs.

Grottke O ，Braunschweig T ，Zimmermann L ，Kopp R ，Lauritzen B ，Coburn M ，Tolba R ，Rossaint R ... -  《-》

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.

Delgado AV ，Kheirabadi BS ，Fruchterman TM ，Scherer M ，Cortez D ，Wade CE ，Dubick MA ，Holcomb JB ... -  《-》