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Clinical Trial to Test Stroke Hemorrhage Treatment

CT scan of stroke victim's brain (National Library of Medicine)
CT scan of stroke victim’s brain (National Library of Medicine)

A clinical trial at University of Nottingham and other sites in the U.K. will test the drug tranexamic acid as a treatment for hemorrhaging in the brain caused by a stroke. The trial is funded by a £2.6 million ($3.9 million) grant from the Health Technology Assessment Programme of the U.K.’s National Institute for Health Research.

About 150,000 people in the U.K. and 795,000 in the U.S. suffer from a stroke each year, causing 1 in 18 deaths in the U.S. The vast majority of stroke victims have an ischemic stroke, caused by a blood clot in the brain that can be treated by clot dissolving drugs, if caught early. In the U.K., some 15 percent of strokes — about 22,000 a year — are caused by a hemorrhage in the brain, for which there is no accepted treatment, and often result in death or disability.

Tranexamic acid is a drug used to treat excessive bleeding in the U.K. that was shown to save lives in a 2010 clinical trial with 20,000 trauma patients in 40 countries. Military physicians in the U.S. and U.K. also use tranexamic acid as a treatment for bleeding.

This new trial will enroll 2,000 people from 120 hospitals and stroke units with a suspected stroke, first in the U.K. and later in other countries. Patients diagnosed through CT scans with bleeding in the brain will be given a chance to participate in the study. Half of those in the trial, selected at random, will be given tranexamic acid within eight hours of their stroke, while half will be given a placebo.

The progress of the patients will be monitored, with a second CT scan given after seven days to determine the amount of blood on the brain. The researchers will follow-up after three months to gauge the patients’ recoveries and determine their level of disability and degree of independence.

Nikola Sprigg of Nottingham’s medical faculty is leading the trial. She says tranexamic acid “could offer new hope for a condition for which there is currently no effective treatment.” Sprigg adds, “If successful, it could potentially improve the lives of thousands of people with hemorrhagic stroke, preventing deaths and reducing disability to increase their chances of leading a full and independent life.”

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