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April 2005 Issue

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International Stroke Study Shows Blood Clotting Agent Saves Patients

Published April 2005

UC scientists working with researchers in Australia, Denmark and Germany have shown that early treatment with a recombinant blood clotting factor can save the lives of patients with a form of stroke known as intracerebral (brain) hemorrhage.

Early treatment with recombinant activated factor VII, marketed as NovoSeven, can also improve the likelihood that brain hemorrhage patients will be able to speak, walk and eat normally again.

Brain hemorrhage, the most deadly kind of stroke, occurs when an artery in the brain bursts and floods adjacent brain tissue with blood. Forty percent of patients with brain hemorrhage die within 30 days, and only 20 percent of survivors recover enough to live independently after a year.

The researchers, including Joseph Broderick, MD, head of UC's neurology department, reported the results of a study of 400 brain hemorrhage patients in the Feb. 24 issue of the New England Journal of Medicine.

The patients were divided into four groups of 100, three of which were treated with small, medium and low doses of NovoSeven, while the fourth received an inactive placebo.

While 69 percent of patients who did not receive NovoSeven died or were severely disabled, the researchers report, the drug reduced the incidence in patients receiving small, medium and low doses to 55, 49 and 54 percent respectively.

Key to the patients' survival, however, Dr. Broderick points out, is that they receive NovoSeven treatment within four hours of onset of intracerebral bleeding.

"Stopping the bleeding as quickly as possible with recombinant factor VII is just one more compelling reason for patients with stroke symptoms to call 911 and get to the hospital as quickly as pos-sible," Dr. Broderick says.

These latest NovoSeven studies are based in part on work done by UC College of Medicine scientists during the late 1980s and 1990s. They were first to demonstrate conclusively that bleeding continues for several hours after onset of a brain hemorrhage and is a major reason for the rapid deterioration in these patients.

The first evidence that NovoSeven represented a possible breakthrough in the treatment of brain hemorrhage was re-ported last year to the 5th World Stroke Congress in Vancouver, Canada.

The principal investigator of the latest study was Stephan A. Mayer, MD, director of neurological intensive care at Columbia-Presbyterian Medical Center, New York. NovoSeven is manufactured by Novo Nordisk, Denmark.

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