Progesterone for the Treatment of Traumatic Brain Injury III
Trial ID or NCT#
NCT00822900
Status
NOT RECRUITING
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.
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
James Quinn
Emergency medicine doctor,
Pediatric emergency medicine doctor
Professor of Emergency Medicine, Emeritus
Anna Finley Caulfield, MD
Neurocritical care specialist
Clinical Associate Professor, Neurology & Neurological Sciences
Chitra Venkatasubramanian, MBBS, MD
Stroke and vascular neurologist,
Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences
Clinical Professor (By courtesy), Neurosurgery
Contact us to find out if this trial is right for you.
Contact
Rosen Mann
6507212645
View on ClinicalTrials.gov