Recombinant factor VIIa and the surgical patient

Bleeding remains a challenge in surgery. A unique drug, recombinant factor VIIa, causes clotting exclusively at bleeding sites. Recombinant factor VIIa has recently been introduced to surgery where current evidence, consisting mostly of case reports, suggest remarkable safety and efficacy. The first randomized controlled trials are only now being published with less remarkable results. This manuscript summarizes the current evidence.

In trauma, a single randomized control trial suggests recombinant factor VIIa reduces bleeding and transfusion in blunt trauma, particularly in coagulopathic patients. In cardiac surgery, one randomized control trial, open-label studies and case reports suggest benefit in refractory bleeding. For liver surgery, randomized control trials do not support use in liver transplant or gastrointestinal bleeding. In neurosurgery, one randomized control trial demonstrated improved outcome in intracerebral hemorrhage. In urology, one randomized control trial demonstrated significant reduction in perioperative bleeding. For orthopedics, a single randomized control trial showed no benefit in pelvic/acetabular surgery. In obstetrics/gynecology, limited evidence suggests benefit in massive bleedings.

Current evidence does not yet support recombinant factor VIIa as standard of care in surgery. However, the evidence indicates that recombinant factor VIIa should be used in intracerebral hemorrhage and massive perioperative or traumatic bleeding refractory to conventional therapies. For now, the bedside decision to use recombinant factor VIIa remains a matter of surgical judgment.