Progesterone for the Treatment of Traumatic Brain Injury III
Trial ID or NCT#
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 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.
- - 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
- - 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
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