Status:
TERMINATED
Progesterone for the Treatment of Traumatic Brain Injury III
Lead Sponsor:
David Wright
Collaborating Sponsors:
Medical University of South Carolina
Neurological Emergencies Treatment Trials Network (NETT)
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
882 Patients enrolled
Trial Details
Trial ID
NCT00822900
Start Date
March 1 2010
End Date
July 1 2014
Last Update
January 20 2016
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
2
Banner Good Samaritan
Phoenix, Arizona, United States
3
Scottsdale Healthcare
Scottsdale, Arizona, United States
4
University of Arizona Medical Center
Tuscon, Arizona, United States, 85724