Progesterone for the Treatment of Traumatic Brain Injury III

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