Recombinant activated factor VII for adjunctive hemorrhage control in trauma

Background. Recombinant activated factor VII (rFVIIa) was approved for trea tment of hemorrhages in patients with hemophilia who develop inhibitors to factors VIII or IX. Conditions with increased thromboembolic risk, includin g trauma with or without disseminated intravascular coagulation, were consi dered a contraindication for the drug. The mechanism of action of rFVIIa su ggests enhancement of hemostasis limited to the site of injury without syst emic activation of the coagulation cascade. Therefore, use of the drug in t rauma 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 mug/kg [range, 120-212 mug/kg]) after failure of conventional measures to achieve hemostasis. Results. Administration of rFVIIa resulted in cessation of the diffuse blee d, with significant decrease of blood requirements to 2 units (range, 1-2 u nits) of packed cells p < 0.05); shortening of prothrombin time and activat ed 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, 46-11 0 seconds) to 41 seconds (range, 28-46 seconds) (p < 0.05), respectively; a nd 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 rFVI Ia may play a role as an adjunctive hemostatic measure, in addition to surg ical hemostatic techniques, and provides the motivation for controlled anim al and clinical trials.