Ultra-early hemostatic therapy for acute intracerebral hemorrhage.

Intracerebral hemorrhage (ICH) is the least treatable form of stroke, and causes high mortality, severe disability, and a staggering economic burden. ICH accounts for 15% of stroke cases in the United States and Europe, and up to 30% in Asian populations. Computed tomography-based studies suggest that ICH growth within the first few hours of onset is common, and the principal cause of early neurological deterioration. Hematoma volume is also a well-established predictor of 30-day mortality. Intervention with ultra-early hemostatic therapy could minimize or prevent this early dynamic bleeding process, and might improve outcome. Recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk, Bagsvaerd, Denmark) is approved for the treatment of bleeding in patients with hemophilia and inhibitors, but it may also promote hemostasis in patients with normal coagulation by acting locally at the bleeding site without activation of systemic coagulation. In a randomized, double-blind, placebo-controlled trial of 399 ICH patients treated with a single dose of 40, 80, or 160 microg/kg of rFVIIa or placebo within 4 hours of onset, subsequent hematoma growth was reduced by approximately 50% with rFVIIa. This was associated with a significant reduction (38%) in mortality, and improved functional outcomes among survivors. A phase III trial comparing 20 and 80 microg/kg rFVIIa with placebo is now in progress to confirm these results.

RCT Entities:   Population Interventions Outcomes