Researchers at the University of Alabama at Birmingham are part of an international study investigating a drug that could potentially stop or slow bleeding in the brain, also known as an intracerebral hemorrhage. Caused by the rupture of a blood vessel in the brain, intracerebral hemorrhage is the second leading cause of stroke, responsible for up to 30 percent of all strokes.
The study, dubbed the FASTEST study, will be conducted at more than 100 hospitals in the United States and abroad. Sponsored by the National Institutes of Health, it will examine a protein called recombinant factor VIIa, or rFVIIa, which the body makes to help stop bleeding at the site of an injury to a blood vessel. rFVIIa is FDA-approved for use in patients who have an inherited lack of clotting factors.
“There is reason to suspect that administering rFVIIa will be effective in slowing or stopping a brain bleed, as we know that it has clotting properties,” said Elizabeth Liptrap, M.D., assistant professor in the UAB Department of Neurosurgery in the Marnix E. Heersink School of Medicine. “And the need is great. Brain injury from intracerebral hemorrhage is usually very severe, with high mortality. Only about 20 percent of patients are able to independently care for themselves six months after injury.”
Patients in the FASTEST study will be randomly placed into one of two groups. One group will get rFVIIa intravenously within two hours of the onset of a brain bleed, while the second group gets a placebo. The two-hour treatment window covers the time when bleeding in the brain is usually most severe. Medical care will be otherwise identical for the two treatment groups, including close management of blood pressure and care within an intensive care unit. There is an enhanced risk of arterial thrombosis, or blood clots, with use of rFVIIa, which investigators will monitor closely.
Due to the severity of a brain bleed, patients may not be able to give their oral or written consent to participate in the study. Liptrap says FASTEST falls within a special set of government rules known as “exception from informed consent.”
EFIC trials are used in instances of a life-threatening illness or injury when the prospective patient population is unconscious or too sick to provide informed consent to be enrolled in a trial. The federal rules for EFIC trials were developed in 1996. EFIC studies are held to the highest ethical standards and undergo scrutiny by multiple agencies. Researchers must show there is reasonable evidence the study has the potential to provide real and direct benefit to the patient. The study must have indications that the study treatment could be more effective and provide better outcomes than other currently available treatments.
The investigators will conduct community outreach to inform the public of the FASTEST study.
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