New Therapy for Cerebral Hemorrhage

The largest clinical trial evaluating the accuracy and efficacy of a new drug for intracerebral hemorrhage (ICH) has just been completed.

ICH is the most lethal and least treatable form of stroke. The new recombinant activated factor used in the trial, called NovoSeven coagulation factor VIIa (rFVIIa), was developed by Novo Nordisk, Inc. (Bagsværd, Denmark). The findings of the study show that this agent restricted hematoma growth and reduced mortality and morbidity compared to placebo.

"One of the strongest predictors of mortality and morbidity in ICH patients is hematoma volume, and with the administration of NovoSeven, hematoma growth was significantly limited,” said lead researcher Dr. Stephan Mayer, associate professor and director, neurological intensive care unit, Columbia University Medical Center (New York, NY, USA). "The current medical and surgical treatment options for ICH are not effective. Thirty-five to 50% of patients die within one month and if they survive, they are living with serious neurological deficits.”

The findings demonstrated that treatment of ICH with this medication within four hours of the beginning of symptoms reduced mortality and improved the three-month clinical outcome, in addition to reducing hematoma growth and in spite of a greater frequency of thromboembolic events. The trial included 399 patients, all diagnosed by computed tomography (CT) imaging within three hours of ICH onset. The study results were published in the March 3, 2005, issue of The New England Journal of Medicine.






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