With 73 sites in 20 countries, this study represents the largest clinical trial ever conducted with a pharmacologic agent for the treatment of ICH. As a physician treating patients over many years with this deadly form of stroke, Dr. Mayer decided to investigate rFVIIa as a treatment for ICH after reading about its coagulation effects. With the brand name NovoSeven, rFVIIa has been on the U.S. market since 1999 as a treatment for hemophilia, and is manufactured by Novo Nordisk.
Preliminary results of this trial were initially presented at the Fifth World Stroke Congress in Vancouver, B.C. in June 2004 and, most recently, at the International Stroke Conference in New Orleans in February 2005.
Study Results
The trial included 399 patients who all underwent a CT scan to confirm they had ICH within three hours of onset. Patients were randomly assigned to receive placebo (N=96), 40 (N=108), 80 (N=92), or 160 (N=103) g/kg doses of rFVIIa within one hour of the baseline scan. The trial results showed that treatment of ICH with rFVIIa within four hours of symptom onset reduced mortality and improved three-month clinical outcome, along with the reduction in hematoma growth, despite a greater frequency of thromboembolic events.
The primary endpoint of the study was to determine if recombinant activated factor VII (rFVIIa) could reduce hematoma growth after ICH. The primary outcome measure was the percent change in ICH volume at 2
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Contact: Elizabeth Streich
eas2125@columbia.edu
212-305-6535
Columbia University Medical Center
23-Feb-2005