Posted on Thu, Jul. 09, 2009
last updated: July 09, 2009 07:43:18 AM
DALLAS — A single dose of the female hormone estrogen could protect the brain after a traumatic injury, but researchers won't know for sure until they test it on humans.
That's what they're doing beginning this week as part of a clinical trial at Parkland Memorial Hospital in Dallas. The participants won't know whether they get estrogen or a placebo. And they won't be able to give their OK before receiving it.
The hormone must be given within two hours of a traumatic brain injury, making it virtually impossible to get informed consent, said Dr. James Simpkins, chair of pharmacology and neuroscience at the University of North Texas Health Science Center in Fort Worth. He is working with a researcher from the University of Texas Southwestern Medical Center at Dallas to translate animal studies to humans.
"If we wait until we can get consent from the person when he recovers consciousness, it will be too late," Simpkins said. "It is crystal-clear that if one waits six hours, 10 hours or more, the ability to protect the brain goes down dramatically."
The groundbreaking research will focus on whether estrogen and anti-inflammatory drugs can prevent secondary injuries and improve outcomes in humans. It will involve 50 North Texas men ages 18 to 50 who have suffered a brain injury or severe blood loss, most likely after an auto, motorcycle or boating accident.
The study will target men because 70 percent of patients with brain injury or blood loss are young males. Studies have suggested that young women, who have high amounts of estrogen, are more resistant to brain trauma than men or older women.
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