Thromboembolic complications associated with factor VIIa administration

Background: Factor VIIa (FVIIa) is given to promote hemostasis in coagulopathic trauma patients at high risk for death. FVIIa is associated with thromboembolic complications, but the incidence is not known, nor is which patients are at risk. We examined our experience with FVIIa to better understand this issue. Methods: Medical records of patients who received FVIIa from 2001 to 2006 were reviewed for evidence of thromboembolic events, including ischemic cardiovascular accident, myocardial ischemia or infarct, mesenteric infarct, peripheral arterial thromboembolism, deep venous thrombosis, or pulmonary embolus. Indication for FVIIa dosing, timing of complication, and clinical outcome were recorded. Each event was assessed by a panel of experienced clinicians to determine the contribution of FVIIa to the event and to patient outcome. Results: Two hundred eighty-five medical records were reviewed. Twenty-seven patients (9.4%) had thromboembolic complications after administration of FVIIa. Nine events were thought to be highly related to FVIIa, and 10 of 14 deaths were, in part, caused by the thrombotic complication. Eighteen of the events, including all cardiovascular accidents and most cases of mesenteric ischemia, were attributed to a combination of FVIIa and a definable, high-energy vascular injury. Conclusion: FVIIa is a potent procoagulant, with the potential for adverse thromboembolic events in susceptible patients. Our experience suggests that caution should be exercised in administration of FVIIa to patients with arterial injuries. Injured mesenteric and cerebral vessels may be especially susceptible to thrombosis.