CINCINNATI—University Hospital (UH) will take part in a nationwide study to determine if the naturally occurring hormone progesterone is effective for treating acute traumatic brain injury.
The National Institutes of Health (NIH) will fund the study of more than 1,100 patients at 17 hospitals in 15 states. The initial award is for approximately $14.5 million over three years. If the early results are promising, researchers will be eligible to apply for another three years and $14 million. Funds will be divided among the study sites based on patient enrollment numbers.
The study—led by Emory University School of Medicine faculty with Atlanta’s Grady Memorial Hospital as the lead center—will examine whether progesterone, delivered intravenously, can lower deaths and improve outcomes after a brain injury. Patients would be randomly assigned to receive standard medical treatment or progesterone with standard therapy shortly after presenting in the emergency department.
Progesterone occurs naturally in both men and women, but is considered a "sex steroid” because it occurs at higher levels in females. It may also act as a protection hormone, as laboratory studies suggest that it exerts protective effects on damaged brain tissue.
"Early work with progesterone suggests that it has very strong beneficial effects, so taking part in this next phase of research is a very exciting opportunity,” says Lori Shutter, MD, director of neurocritical care at University Hospital and the University of Cincinnati (UC) Neuroscience Institute and an associate professor of neurosurgery at UC.
"With brain trauma, we can’t undo the initial injury but we do hope to reduce the secondary injury caused by swelling. Progesterone may have a role in that process.”
Arthur Pancioli, MD, an associate professor in UC's emergency medicine department, is the local site principal investigator for the Neurological Emergency Trials Treatment (NETT) Network, which is coordinating the study. Shutter is a co-investigator.
The study is called ProTECT III (Progesterone for Traumatic brain injury—Experimental Clinical Treatment) and is the third phase of a study evaluating progesterone’s effectiveness in treatment of acute traumatic brain injury. It is an outgrowth of research by Donald Stein, PhD, an Emory neuroscientist.
David Wright, MD, an assistant professor of emergency medicine at Emory and the study’s lead investigator, says an earlier clinical trial showed 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.
A significant traumatic brain injury occurs in approximately 1.5 to 2 million adults and children in the United States 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. In addition, traumatic brain injuries have been labeled the "signature wound” of U.S. soldiers in Iraq and Afghanistan.
"This is a major problem for the young people of our country,” Shutter says of traumatic brain injury. "In addition, there’s a second peak in head injuries for people over 50 that is often related to falls, and the older patient often doesn’t recover as well.”
University Hospital, part of the Health Alliance, is home to Greater Cincinnati’s only Level I trauma center. It serves as the primary teaching hospital for the UC College of Medicine and provides primary care and specialized inpatient and outpatient services to more than 500,000 patients per year.