A new and promising study is underway to determine if progesterone, a natural hormone, is effective in decreasing disability, including brain damage, in patients following a traumatic brain injury (TBI). This nationwide study, called the ProTECT III study, is hoping to confirm what has been found in both animal and pilot studies, which have all discovered that progesterone treatment following severe brain injury could safely and effectively reduce the risk of serious disability and death.
“If this study proves that using progesterone in traumatic brain injury cases works, this would be the most promising breakthrough in improving outcomes for traumatic brain injury patients,” claims Nina Gentile, head of the regional study and professor of emergency medicine at the School of Medicine at Temple University in Philadelphia.
What is the ProTECT III study?
The ProTECT III study is a nationwide study designed to compare the effects of standard treatment versus standard treatment plus progesterone therapy in patients following traumatic brain injury.
This study is taking place at level-I trauma centers in numerous hospitals around the country including Philadelphia’s Hahnemann, Thomas Jefferson, and Temple hospitals, and Pennsylvania’s Penn State-Hershey Medical Center and Geisinger Medical Center. Temple University Hospital will serve as a regional hub for the study.
In each of these studies, patients who are admitted to the hospital with a TBI will be given the standard brain injury care, including blood pressure and oxygen level control measures, as well as surgery if necessary to limit brain damage. In addition to this standard treatment, some patients will be randomly assigned to receive progesterone treatment for four days. Others will receive a placebo.
Given the supreme importance of immediate medical care following a traumatic brain injury, the FDA has agreed to waive the informed consent rule for this study. However, hospitals will try to contact the patient’s family prior to administering this experimental treatment.
Following treatment, all patients will receive follow-up calls and visits with members of the study team in order to track their progress.
Past Studies of Progesterone and TBI
In the past, numerous animal studies have discovered that progesterone treatment following traumatic brain injury can result in less brain damage. Furthermore, two pilot human studies have found that progesterone can reduce disability in TBI patients safely and effectively when given shortly after the injury is sustained. In one of these studies, those given progesterone were half as likely to die from brain injury complications, compared to those on standard treatment. Furthermore, the progesterone did not appear to have any negative effects on those receiving this treatment.
The ProTECT III study will test these previous findings to determine if progesterone can reduce the damage caused by TBI.
