ProTECT III: Progesterone for the Treatment of Traumatic Brain Injury

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Investigator: Geoffrey Manley, MD, PhD
Sponsor: Emory University

Location(s): United States

Description

The purpose of this trial is to determine if progesterone is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.

According to the Centers for Disease Control and Prevention, approximately 1.5 to 2 million adults and children in the United States suffering from traumatic brain injuries each year, leading to 50,000 deaths and 80,000 new cases of long-term disability.

Progesterone is a protection hormone naturally present in small but measurable amounts in the human brain.  In an earlier study, researchers found that progesterone given to trauma victims shortly after brain injury appears to be safe and may reduce the risk of death and long-term disability.  They hope to confirm these preliminary findings and determine if progesterone benefits victims of acute traumatic brain injury.

This multicenter, randomized, double-blinded study will enroll 1140 participants at multiple hospitals across the US.  In this study, researchers will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours) along with standard medical care for brain injury is more effective at limiting the amount of damage caused by a traumatic brain injury than standard medical care alone.