Progesterone for the Treatment of Traumatic Brain Injury III
Progesterone for the Treatment of Traumatic Brain Injury III
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of
 injury and given for a total of 96 hours), is more effective than placebo for treating
 victims of moderate to severe acute traumatic brain injury.
Inclusion Criteria:

 -  Moderate to severe brain injury (GCS 12-4)

 -  Age 18 years or older

 -  Blunt, closed head injury

 -  Study drug initiated within 4 hours of injury

 Exclusion Criteria:

 -  Non-Survivable injury

 -  Bilateral dilated unresponsive pupils

 -  Severe intoxication (ETOH > 250 mg %)

 -  Spinal cord injury with neurological deficits

 -  Inability to perform activities of daily living prior to injury

 -  Cardiopulmonary arrest

 -  Status epilepticus on arrival

 -  Systolic blood pressure (SBP) < 90 on arrival or for at least 5 minutes prior to
 enrollment

 -  O2 Sat < 90 on arrival or for at least 5 minutes prior to enrollment

 -  Prisoner or ward of state

 -  Pregnant

 -  Active breast or reproductive organ cancers

 -  Known allergy to progesterone or intralipid components (egg yolk)

 -  Known history of clotting disorder

 -  Active thromboembolic event

 -  Concern for inability to follow up at 6 months

 -  Anyone listed in the Opt out registry