Progesterone for the Treatment of Traumatic Brain Injury III
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: Progesterone; Placebo
Intervention description: Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 71 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.; Placebo stock solution is the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid is based on the mg/kg/hr volume. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid is administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours.
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 882.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Trauma; Brain Injury

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.
    

Eligibility 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