Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial

Abstract

Background and Purpose: Ultra-early hemostatic therapy may improve outcome after intracerebral hemorrhage (ICH) by preventing rebleeding and hematoma expansion. We conducted this trial to evaluate the safety of activated recombinant factor VII (rFVIIa; NovoSeven®) for preventing early hematoma growth in acute ICH. Methods: In this multicenter, randomized, double-blind, placebo-controlled, doseescalation trial, 40 patients diagnosed with ICH by computed tomography within 3 hours of onset were treated with placebo or 5, 20, 40, or 80 μg/kg of rFVIIa ( n = 8 per group). Patients with any history of thromboembolic or vaso-occlusive disease were excluded. The primary endpoint was the frequency of..