Complications of Recombinant Activated Human Coagulation Factor VII

Background: Recombinant factor VIIa (rFVIIa) frequently is used for treatment of life-threatening hemorrhage in trauma.

Methods: A retrospective review of injured patients receiving rFVIIa at an American College of Surgeons-verified Level 1 trauma center was performed. Controls were matched for age, sex, Injury Severity Score, and traumatic brain injury. Thrombotic complications in patients administered rFVIIa, including deep venous thrombosis (DVT), pulmonary embolus, acute myocardial infarction, ischemic stroke, mesenteric ischemia, arterial thromboembolism, and death, were determined.

Results: Thirty-six patients were given rFVIIa, of whom 5 (13.8%) had thrombotic complications. Indications for rFVIIa were life-threatening intracranial bleeding in the presence of pre-injury anticoagulation or hemorrhage. The incidences of DVT (n = 4) and acute myocardial infarction (n = 1) were noted. In the control group, there were fewer thrombotic complications (DVT, 1; pulmonary embolus, 1). The mortality rate (52.8%) was higher in patients receiving rFVIIa compared with the control group (22.2%; P = .014). Pre-injury anticoagulation was common in the treatment group.

Conclusions: Pre-injury anticoagulation is frequently the indication for rFVIIa administration. Thrombotic complications occur with rFVIIa administration. The mortality rate of injured patients who receive rFVIIa is high.