NovoSeven may prove to be the first effective treatment for brain hemorrhage caused by stroke

Jul 5 2004

Scientists from the UC Medical Center played a key role in developing what may prove to be the first effective treatment for brain hemorrhage caused by stroke.

The possible breakthrough in the treatment of brain (intracerebral) hemorrhage, a recombinant clotting factor to be marketed as NovoSeven, was announced Saturday to the 5th World Stroke Congress in Vancouver, Canada.

NovoSeven is a naturally occurring clotting factor (also referred to as factor seven). It’s already approved for treating hemophiliacs, who lack certain clotting factors, to stop bleeding.

Researchers who studied NovoSeven’s efficacy against brain hemorrhage found that it reduced bleeding, and subsequent disabilities associated with it, when treatment was administered early after the onset of symptoms.

According to Joseph Broderick, MD, professor and director of neurology at UC Medical Center, “This study will eventually change the way people in Cincinnati and across the world are treated for stroke.

“The research emphasizes once again how important it is to get to the hospital quickly, at the first symptoms of a stroke,” says Dr. Broderick, a member of the study’s steering committee and a co-author of the NovoSeven report.

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 NovoSeven study was based in part on work done by researchers at UC College of Medicine 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 larger the blood-filled pocket (hematoma), the more severe the brain damage and the greater likelihood of death.

Before UC scientists discovered otherwise, it was thought that brain bleeding occurred just for a few minutes following stroke. UC’s findings led to the possibility of a therapy, such as the activated factor seven used in NovoSeven, that could be given to stop the ongoing bleeding.

The results presented at the World Stroke Congress were based on 400 patients in Europe. These patients underwent a CT brain scan within three hours of the onset of the stroke to confirm bleeding. Of four groups treated, one received a placebo while the others received different set dosages of activated factor seven.

Patients with stroke caused by blockages are normally treated with tissue plasminogen activator (t-PA), a substance normally made by the body to break up blood clots. The earliest studies of t-PA were also done in Cincinnati through the cooperation of local hospitals and members of the Greater Cincinnati Stroke Team.

NovoSeven is manufactured by Novo Nordisk, a health-care company based in Bagsvaerd, Denmark.