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Pharmaceutical study: Less hemorrhaging after stroke, but not fewer deaths
Date:6/11/2008

An international study published in May 2008 in the New England Journal of Medicine has shown that the coagulation factor VIIa can limit the extent of a cerebral hemorrhage. However, in the long term it does not prevent death or severe impairment.

Further studies must clarify whether the new treatment with the genetically engineered substance is suitable for a special group of patients who as the study suggests could profit from therapy in spite of this. These are patients with a limited hemorrhage size (delta 60ml), with limited amounts of blood in the cerebrospinal fluid space (delta 5ml), who are not over an age 70 years and who will be treated within 2.5 hours or less.

Some 841 patients in 73 centers in 20 countries took part in the study. Member of the steering committee, study coordinator for Europe, and co-author of the published article is Professor Dr. Thorsten Steiner, Senior Physician at the Department of Neurology, University of Heidelberg Hospital (Medical Director: Professor Dr. Werner Hacke).

Cerebral hemorrhages account for 15 percent of all strokes. They are often fatal; some 80 percent of the surviving patients are severely disabled. Especially problematic is further increase of the hematoma, which occurs in one third of patients in the first four hours. Thus far there is no way of treating.

An earlier study proved reduction of outcome and mortality

Three years ago, a phase-2 study with recombinant coagulation factor VIIa with the trade name NovoSeven, which is not yet approved for clinical use, showed that the compound could lower the death rate after a hemorrhage and limit impairment. This study was also published in the "New England Journal".

The new study compares the effectiveness of factor VIIa in two dosages (20 and 80 micrograms) with a placebo. The extent of the hemorrhage visible on a CT scan was noticeably larger (26%) in the placebo group than in the patien
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Contact: Dr. Annette Tuffs
annette.tuffs@med.uni-heidelberg.de
49-622-156-4536
University Hospital Heidelberg
Source:Eurekalert

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