VCU Medical Center to Study Use of Progesterone in Acute Traumatic Brain Injury

By Anne Buckley

Virginia Commonwealth University researchers are gearing up to participate in a nationwide study of the use of progesterone, a hormone that occurs naturally in the body, to treat patients with an acute, severe traumatic brain injury.

The National Institutes of Health Phase III clinical trial, called ProTECT III, is being conducted at 17 institutions across the United States. The VCU Medical Center is the only participating hospital in Virginia.

Before the study gets under way, researchers are conducting a series of public meetings and community outreach efforts in Richmond and surrounding counties to inform the public that participants may be enrolled in the study without their consent or that of a family member, a provision allowed under federal regulations that permits qualified clinical research in emergency settings without informed consent.

Because study participants will include critically injured patients who are generally not able to communicate, individuals are being informed that they can opt out of the study now by obtaining a bracelet and placing their name in a national opt out registry. Individuals who opt out of the study still will receive the standard medical treatment for brain injury.

The study will examine if treatment with progesterone for the first four days following a traumatic brain injury, or TBI, improves the outcome of these patients. Previous studies suggest that progesterone, given immediately after a TBI, may help treat brain injuries by reducing brain swelling and damage.

TBI is a major cause of premature death and disability worldwide. In the U.S. approximately 2 million Americans sustain a TBI, leading to 50,000 deaths and 235,000 hospitalizations annually. No therapy has been found to be effective for reducing mortality and improving functional outcomes.

More information about the study and how to opt out can be obtained by contacting the VCU Health System Department of Neurosurgery, Box 980631, Richmond, VA, 23298-0631, by telephone at 804-828-1456, or by email at protect@vcu.edu.