January 25, 2010

Emory to lead study on brain injury

The city of Atlanta will serve as the national epicenter for a groundbreaking National Institutes of Health-sponsored trial for the treatment of traumatic brain injuries using the hormone progesterone.

The study, called ProTECT III (Progesterone for Traumatic brain injury – Experimental Clinical Treatment), will enroll 1,140 patients over five years at 17 medical centers in 15 states. Grady Memorial Hospital will serve as the lead center.

The initial NIH award of approximately $14.5 million is for three years and could be extended.

David Wright, associate professor of emergency medicine, is the lead investigator. Michael Frankel, professor of neurology, and Jeffrey Salomone, associate professor of surgery, will be site principal investigators.

In an earlier pilot clinical trial, says Wright, “We found evidence that progesterone is not only safe for use in patients suffering from traumatic brain injuries. We also found a 50 percent reduction in mortality in those patients treated with progesterone . . . we found signs that progesterone improved functional outcomes and reduced disability in patients with moderate brain injury.”

Donald G. Stein, Asa G. Candler Professor of Emergency Medicine, pioneered discoveries regarding the effect of progesterone following traumatic brain injury in the laboratory over 25 years ago.

“My work first started when I began to notice evidence that women tended to respond to treatment and recover better than men after suffering from brain injury and stroke,” Stein says. “Ultimately, we learned that progesterone basically does in brain injuries what it also does during fetal development - protect cells and tissue.”

Wright notes, “No new treatment for severe TBI has been approved in over 30 years. With such promising success in laboratory testing and in our previous clinical trial, we certainly hope to conclude that this national trial — along with standard medical trauma care — works better than standard medical care alone in reducing brain damage caused from a TBI.”

Under special rules the Food and Drug Administration created for ProTECT III, called “Exception from Informed Consent,” patients may get the progesterone hormone without consent of next-of-kin, in large part because success of the drug is highly dependent on being administered to the patient as quickly as possible after sustaining a brain injury.

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