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(Stroke. 2007;38:763.)
© 2007 American Heart Association, Inc.

Intracerebral Hemorrhage: Introduction

Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage

Stephan A. Mayer, MD, FCCM

From the Neurological Intensive Care Unit, Columbia University Medical Center, New York, NY.

Correspondence to Stephan A. Mayer, MD, Neurological Intensive Care Unit, Neurological Institute, 710 West 168th Street, Box 39, New York, NY 10032. E-mail sam14{at}columbia.edu

Abstract

Intracerebral hemorrhage is the least treatable form of stroke and is associated with 30% to 50% mortality rate. Early hematoma growth occurs in 18% to 38% of patients scanned within 3 hours of intracerebral hemorrhage onset, and hematoma volume is an important predictor of poor outcome. Recombinant activated factor VII, a potent initiator of hemostasis, is currently approved for the treatment of bleeding in hemophilia patients with inhibitors and has also been shown to promote hemostasis in patients with normal coagulation. A recent phase IIB randomized, double-blind, placebo-controlled, dose-ranging "proof-of-concept" trial enrolled 399 intracerebral hemorrhage patients to determine whether recombinant activated factor VII can limit ongoing bleeding and improve outcome. An approximate 50% relative reduction in hematoma growth was evident with all 3 doses that were tested (40, 80, and 160 µg/kg), which translated into an average reduction in absolute intracerebral hemorrhage volume growth of 5 milliliters. More importantly, recombinant activated factor VII was associated with a 38% relative reduction in mortality and significantly improved functional outcome among survivors, despite a 5% frequency of arterial thromboembolic events (primarily ischemic stroke and myocardial infarction). A large phase III trial (the FAST trial [Factor Seven for Acute Hemorrhagic Stroke Treatment]) is now in progress to confirm these findings.

Key Words: intracerebral hemorrhage • recombinant activated factor VII

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