Recombinant Factor VIIa Does Not Benefit ICH

Background: Recombinant factor VIIa is known to lessen bleeding in intracerebral hemorrhage (ICH) but, like other hemostatic agents, has never been noted to improve clinical outcomes. Objective: To evaluate the rate of hematoma growth, safety, and clinical effects of factor VIIa among patients with spontaneous ICH (sICH). Design: Multicenter, prospective, double-blind phase 3 trial. Participants/Methods: 626 adult patients from 93 sites in 6 countries with sICH and/or intraventricular hemorrhage (IVH) from 2021 to 2025 were included. Glasgow Coma Scale score was ≥8 and patients were treated within 2 hours of the sICH/IVH. Patients were randomized to receive either 80 μg/kg of recombinant factor VIIa or placebo. Results: 65% of patients were male, and mean age was 61 years. Mean time from stroke presentation to drug administration was 100 minutes. For the primary outcome of modified Rankin Scale at 180 days, there was no significant difference. Serious thromboembolic complications wit more...