As an influx of veterans leave the battlefield, many are returning with severe traumatic brain injuries (TBI), a common result of blast injuries and other blunt force trauma.

TBI, which often results in lifelong disability and even death, affects as many as 1.7 million Americans per year. Assistant professor in the department of emergency medicine Dr. Mark Saks and fellow researchers from Drexel University College of Medicine are helping to lead a clinical trial that aims to secure a safe way to ease the symptoms of the condition.
The clinical trial, known as ProTECT III, is sponsored by the National Institutes of Health and is based at Emory University. The trial’s main focus is the effects of the hormone progesterone on patients with moderate to severe TBI.

Though commonly known as a female sex hormone, progesterone is present in varied amounts in both men and women—and it may have an effect on central nervous system functions.
Multiple animal studies have shown progesterone to reduce the effects of TBI, and two pilot studies have shown that the hormone may reduce mortality and brain damage in humans if given soon after TBI occurs. Progesterone has a long history of safe use in men and women, and Saks and his colleagues are learning it may help make the difference between patients being condemned to a future of round-the-clock care or only needing minimal assistance.

But not all TBI patients can qualify for the study. With the help of the emergency team, Saks and Dr. Romy Nocera, clinical research director for Drexel Emergency Medicine, screen potential patients for the study when they enter the Charles C. Wolferth Trauma Center at Hahnemann University Hospital.

To be included, the patient must be unconscious and likely to have suffered serious—anywhere between 4 and 12 on the neurological standard Glasgow Coma Scale—but survivable injuries. The brain injury must be “closed,” or caused by movement of the brain within the skull. Penetrating injuries, such as bullet wounds, do not qualify. Finally, the protocol requires treatment to begin within four hours of the injury, when it may still be possible to prevent secondary damage.

Once a patient is selected for the study, he or she will receive intravenous progesterone or a placebo. The treatment is given continuously for 72 hours, and then tapers off over the course of 24 hours. The study is double-blind, so the study team does not know whether or not the patient is receiving the drug or the placebo. Treatment is followed with monthly follow-up calls from Nocera, and the patient returns for an extensive assessment by a neuropsychiatric tester who is not part of the study.

The leading causes of TBI include falls, traffic accidents, assaults and being struck by objects. Every year, 52,000 people will die from TBI complications, and as many as 275,000 will be hospitalized. Nationally, 59 percent of patients suffering from TBI are male.