Treatment with the hormone progesterone provided no significant benefits to patients who had suffered a traumatic brain injury, according to the results of a nationwide clinical trial involving more than 800 patients.
OHSU was one of 48 trauma centers nationwide that participated in the trial from July 2009 to November 2013. Study results were published last month in the New England Journal of Medicine.
The study was designed to include 1,140 patients but was stopped after 882 patients because there was no difference in patient survival or favorable outcomes in the progesterone-treated group versus the placebo-treated group.
Scientists had hoped that progesterone might help in traumatic brain injury because of previous animal and smaller human research trials that found progesterone seemed to protect brain cells from the toxic environment that emerges after traumatic injury.
“There was some evidence in smaller studies before this trial that progesterone might be beneficial for patients with head injuries. But, unfortunately, we did not see those same benefits with this large group of patients” said Craig Warden, M.D., a professor of emergency medicine in the OHSU School of Medicine, and principal investigator for the OHSU study site.
The study was considered an “exception from informed consent” study, regulated by the Food and Drug Administration. It applies to limited medical research in which human subjects are in need of emergency medical intervention but cannot give informed consent prior to participating because of their life-threatening medical condition.
The federal regulations that allow this exception require community consultation and notification to ensure the public is aware of the study. After a patient is enrolled, informed consent to continue with study treatment is obtained from the patient or their family as soon as it is feasible.
The study was funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health (project # 1U01NS062778).