Recombinant Activated Factor VII for Adjunctive Hemorrhage Control in Trauma*

Abstract

SUMMARY Background: Recombinant activated factor VII (rFVIIa) was approved for treatment of hemorrhages in patients with hemophilia who develop inhibitors to factors VIII or IX. Conditions with increased thromboembolic risk, including trauma with or without disseminated intravascular coagulation, were considered a contraindication for the drug. The mechanism of action of rFVIIa suggests enhancement of hemostasis limited to the site of injury without systemic activation of the coagulation cascade. Therefore, use of the drug in trauma patients suffering uncontrolled hemorrhage appears to be rational. Methods: Seven massively bleeding, multitransfused (median, 40 units [range, 25–49 units] of packed cells), coagulopathic trauma patients were treated with rFVIIa (median, 120 μg/kg [range, 120–212 μg/kg]) after failure of conventional measures to achieve hemostasis. Results: Administration of rFVIIa resulted in cessation of the diffuse bleed, with significant decrease of blood requirements to 2 units (range, 1–2 units) of packed cells (p < 0.05); shortening of prothrombin time and activated partial thromboplastin time from 24 seconds (range, 20–31.8 seconds) to 10.1 seconds (range, 8–12 seconds) (p < 0.005) and 79 seconds (range, 46–110 seconds) to 41 seconds (range, 28–46 seconds) (p < 0.05), respectively; and an increase of FVII level from 0.7 IU/mL (range,0.7‐0.92 IU/mL) to 23.7 IU/mL (range, 18–44 IU/mL) (p < 0.05). Three of the seven patients died of reasons other than bleeding or thromboembolism. Conclusion: The results of this report suggest that in trauma patients rFVIIa may play a role as an adjunctive hemostatic measure, in addition to surgical hemostatic techniques, and provides the motivation for controlled animal and clinical trials.