Emory announces third phase of progesterone for brain injury study
Emory University officials recently announced the third phase of a groundbreaking study to evaluate the effectiveness of the hormone progesterone on acute traumatic-brain-injured patients.
Backed by a grant from the National Institutes of Health (NIH), the Emory-led, multicenter, randomized, double-blinded study will enroll 1,140 patients at 17 medical centers in 15 states. Atlanta’s Grady Memorial Hospital will serve as the lead center, led by Emory University School of Medicine faculty researchers, in concert with colleagues from the Morehouse School of Medicine.
The initial award will be for three years and a total of approximately $14.5 million, to demonstrate target feasibility to conduct the trial. If milestones are met during the first three years, the trial could be extended for three more years with additional funding of approximately $14 million.
David Wright, M.D., assistant professor of emergency medicine at Emory School of Medicine, is the national study’s lead investigator. Michael Frankel, M.D., Emory professor of neurology, will serve as site principal investigator of the clinical trial at Grady. The University of Michigan will provide the central study oversight and coordination. Data analysis will occur at the Medical University of South Carolina.
Emory researchers concluded in an earlier clinical trial that giving progesterone to trauma victims shortly following brain injury appears to be safe and may reduce the risk of death and long-term disability. Their three-year study enrolled 100 participants. It was designed to evaluate whether progesterone can be administered intravenously in a safe and reliable way.
“We found evidence that progesterone is not only safe for use in patients suffering from traumatic brain injuries – showing no evidence of side effects or serious harmful events. We also found a 50 percent reduction in mortality in those patients treated with progesterone,” said Wright. “Furthermore, we found signs that progesterone improved functional outcomes and reduced disability in patients with moderate brain injury.”
Although it is widely considered a “sex steroid,” progesterone is also a protection hormone. It is naturally present in small but measurable amounts in the brains of males and females. Human brain tissue is loaded with progesterone receptors. Laboratory studies suggest that progesterone is critical for the normal development of neurons in the brain and exerts protective effects on damaged brain tissue.
Donald G. Stein, Ph.D., Asa G. Candler Professor of Emergency Medicine at Emory School of Medicine and director of Emory’s Department of Emergency Medicine Brain Research Laboratory, pioneered discoveries regarding the effect of progesterone following traumatic brain injury more than 25 years ago.
“The results that we are now seeing, and hope to continue validating, are an incredible and gratifying reward for more than 25 years of concentrated research,” said Stein.
Every 15 seconds, a U.S. citizen sustains a significant traumatic brain injury, with approximately 1.5 to 2 million adults and children in the United States suffering from these injuries each year, leading to 50,000 deaths and 80,000 new cases of long-term disability, according to the Centers for Disease Control and Prevention.
“The NIH grant is more than an outstanding achievement for Emory, it is a significant advancement in the care that Grady Hospital will be able to provide our brain trauma patients,” said Michael Young, CEO of Grady Health System. “The research and cutting-edge treatment resulting from this grant will once again demonstrate that the Emory-Grady partnership improves the quality of life for patients here and well beyond the metro Atlanta area.”
Traumatic brain injuries have also been labeled the “signature wound” of U.S. soldiers in the field of battle – particularly in recent conflicts in Iraq and Afghanistan, and the number of military personnel impacted by blunt trauma traumatic brain injury has risen dramatically in recent years. |
