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Progesterone for the Treatment of Traumatic Brain Injury III
Not Recruiting
Trial ID: NCT00822900
Purpose
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
Professor of Emergency Medicine, Emeritus
Anna Finley Caulfield, MD
Clinical Professor, Neurology & Neurological Sciences
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Peter D'Souza
Clinical Associate Professor, Emergency Medicine
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
Intervention(s):
drug: Progesterone
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Rosen Mann
6507212645