Progesterone for the Treatment of Traumatic Brain Injury III

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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 to severe acute traumatic brain injury.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Wright
• Collaborators: Medical University of South Carolina; Neurological Emergencies Treatment Trials Network (NETT)
• Treatments: Progesterone; Soybean oil, phospholipid emulsion

Criteria

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