CLEVELAND -- MetroHealth Medical Center is testing progesterone as a possible treatment for traumatic brain injury.
The study, otherwise known as Synapse, evaluates the safety and effectiveness of intravenous progesterone infusion as a neuroprotective agent for treating severe, closed-head traumatic brain injury patients.
Metro's already enrolled ten patients in the study. They received a five-day continuous intravenous infusion of progesterone, beginning within eight hours of injury.
"We hope to provide more treatment options for patients who have devastating head injuries," said Jeffrey Claridge, MD, the director of the Division of Trauma, Critical Care, and Burns.
Trauma is the leading cause of death and head injuries are the major cause of disability.
The trial is double blind, meaning neither doctors nor patients know who's getting the progesterone and who's getting the placebo.
Progesterone was shown in several clinical trials to have significant neuroprotective properties that can be instrumental in improving TBI outcomes.
Patients enrolled must be 16 to 70 years old, have serious closed-head injuries, no gunshot or other penetrating wounds, must begin treatment within eight hours of being injured and have a family member available to consent to their participation in the study.
Patients are followed for six months, at which point they will be evaluated using the Glasgow Outcome Scale (GOS) - the primary study endpoint.
Results should be available in 2014.