Study Objective: To examine our institutional experience with recombinant Factor VIIa (rFVIIa) as a treatment for exsanguinating hemorrhage in critically ill trauma patients. Design: Retrospective case review. Setting: A specialized trauma and critical care hospital, serving as the quaternary referral center for trauma and surgical shock in the state of Maryland. Patients: All patients with diffuse coagulopathy and impending exsanguination, given rFVIIa in an effort to control life-threatening hemorrhage. Patients were in the intensive care unit (ICU) or operating room (OR) and included both acute admissions and late-stage patients with multiple organ system failure. Interventions: Patients of interest were those that had received rFVIIa. Measurements: Examination of medical records, including pharmacy data, laboratory results, and the institutional trauma registry. Main Results : Administration of rFVIIa contributed to successful control of hemorrhage in three of five patients. Failure in two Patients was mostly likely due to overwhelming shock and acidosis. Conclusions: Administration of rFVIIa shows promise in the treatment of exsanguinating hemorrhage. Prospective, controlled clinical trials of this therapy are strongly recommended. (C) 2003 by Elsevier Science Inc.