A new multi-center, international study led by Columbia University Medical Center researchers at NewYork-Presbyterian Hospital/Columbia shows that recombinant activated factor VII (rFVIIa) has the potential to be a significant advance in treating bleeding stroke (acute intracerebral hemorrhage or ICH). Published in the New England Journal of Medicine (Feb. 24 issue), the study found a reduction in hematoma growth (bleeding in the brain), decreased mortality, and improvement in neurological and clinical outcomes in patients treated with rFVIIa compared to placebo.

ICH is the deadliest and most disabling type of stroke more than one out of three ICH patients die within one month of onset and only 20% regain functional independence. Physicians have long been frustrated by a lack of effective therapies to improve survival outcomes or recovery current options are only supportive. RFVIIa is currently entering phase III trials as an investigational treatment for ICH. If approved by the U.S. Food and Drug Administration, it will become only the second emergency treatment for stroke in more than three decades the first was TPA, approved by the FDA in 1996.

"Current medical and surgical options for ICH are not effective. Thirty-five to 50 percent of patients die within one month and if they survive, they live with serious neurological deficits. Current data suggest a possible change in our paradigm for the treatment of ICH," said Stephan A. Mayer, M.D., principal investigator of the study. Dr. Mayer is an associate professor of neurology and neurosurgery at Columbia University College of Physicians and Surgeons, and director of the Neurological Intensive Care Unit at NewYork-Presbyterian Hospital/Columbia.

"I approached this study with modest expectations, expecting to see some trends toward improved outcomes," noted Dr. Mayer. "I was stunned to find that by preventing just 5 ml of additional blood about one teaspoon of bleeding in
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Contact: Elizabeth Streich
eas2125@columbia.edu
212-305-6535
Columbia University Medical Center
23-Feb-2005

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