ProTECT III is the name of a research study that looks at using progesterone (a hormone) to treat brain injury caused by an accident or other acute trauma. Researchers compared the effectiveness of progesterone to a placebo.
About the study
This study took place between July 2009 and November 2013. Researchers and physicians studied patients from 49 trauma centers across the United States. While researchers had planned to include 1,140 patients, they stopped after 882 because they felt that the results would not change by enrolling more patients.
One of the trauma centers in this study was Froedtert Hospital in Milwaukee, Wisconsin. A total of 73 patients were enrolled. The average age of patients in this group was 38. Here is more to know about Froedtert’s patients in the study:
• 53 patients (73%) were male
• 20 patients (27%) were female
• 59 patients (81%) were Caucasian
• 9 patients (12%) were African American
• 9 patients (12%) were Hispanic
• 3 patients (4%) were Asian
• 2 patients (3%) were American Indian/Alaska Native
Study results
ProTECT III found that using progesterone to treat patients with acute traumatic brain injury provides no significant benefit compared to treatment with a placebo. We found that Glasgow Coma Scores (an assessment of the severity of brain injury), survival rates and favorable outcomes were nearly the same.
Patients taking either progesterone or the placebo had about the same amount and type of side effects. The only significant difference was that those taking progesterone had a higher risk of getting phlebitis (inflammation of a vein) than those taking the placebo. Results of this study were published in the December 2014 issue of the New England Journal of Medicine.
To learn more about this study, visit the ProTECT website at www.protectiii.com, or contact Dr. Tom Aufderheide at (414) 805-6493 or email at RRC@mcw.edu
