Progesterone for the Treatment of Traumatic Brain Injury III

Not Recruiting

Trial ID: NCT00822900


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.

Official Title

Phase 3 Clinical Trial to Determine if Progesterone Along With Standard Medical Care for Brain Injury is More Effective at Limiting the Amount of Damage Cause by a Traumatic Brain Injury Than Standard Medical Care Alone.

Stanford Investigator(s)

James Quinn
James Quinn

Professor of Emergency Medicine, Emeritus

Anna Finley Caulfield, MD
Anna Finley Caulfield, MD

Clinical Professor, Neurology & Neurological Sciences

Peter D'Souza

Clinical Associate Professor, Emergency Medicine

Chitra Venkatasubramanian, MBBS, MD
Chitra Venkatasubramanian, MBBS, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery


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

   - 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


drug: Progesterone

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann