Progesterone for the Treatment of Traumatic Brain Injury III

Trial ID or NCT#

NCT00822900

Status

not recruiting iconNOT 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:
  1. - 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:
  1. - 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
James Quinn
Emergency medicine doctor, Pediatric emergency medicine doctor
Professor of Emergency Medicine, Emeritus
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Stroke and vascular neurologist, Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Peter D'Souza
Emergency medicine doctor
Clinical Associate Professor, Emergency Medicine
Anna Finley Caulfield, MD
Anna Finley Caulfield, MD
Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences

Contact us to find out if this trial is right for you.

Contact

Rosen Mann
6507212645