Closure of ProTECT III Clinical Trial
The University of Maryland School of Medicine Departments of Neurosurgery and Neurology have completed their participation in a clinical research study called “ProTECT III.” This nationwide study, funded by the National Institutes of Health, was investigating whether treatment of acute traumatic brain injury (TBI) with the hormone progesterone would provide benefit to patients. The study determined that there was no significant benefit to patients who received progesterone when compared to those who received placebo.
The study involved 49 trauma centers across the United States between July 2009 and November 2013. The study originally planned to include 1,140 patients, but was stopped after 882 patients because safety monitors determined that additional enrollment would be futile.
Survival and favorable outcomes, measured by improvements in patients’ Glasgow Coma Scores, were not significantly different in the progesterone-treated group than in the placebo-treated group. Favorable outcomes occurred in 51 percent of those who received progesterone and 56 percent of those who received placebo. Mortality after six months was 18.8 percent for progesterone and 15.7 percent for placebo.
Progesterone, administered by infusion for four days, was generally well tolerated, with similar rates of adverse events in both progesterone- and placebo-treated groups. Phlebitis (inflammation of a vein) was more common in the progesterone group.
Due the sudden and often severe nature of traumatic brain injuries in which the patient may not have had the ability to consent to trial participation, the trial was governed by protocols set forth by the U.S. Food and Drug Administration’s “Exception from Informed Consent.” People in our community who did not wish to become enrolled in the study in the event of TBI were provided a bracelet with the words “ProTECT III declined.” Anyone in the community wearing those bracelets may discard them at this time.
For detailed information about the ProTECT III study and trial results, visit www.protectiii.com.
Patients or physicians with questions specific to the University of Maryland’s participation in the study and subsequent closure, please contact study site coordinator Virginia Ganley, University of Maryland School of Medicine Department of Neurology, firstname.lastname@example.org or 1-800-492-5538.