Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

David Wright

Collaborator: Neurological Emergencies Treatment Trials Network (NETT)

Intervention(s):

  • Drug: Progesterone
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann
6507212645
Not Recruiting