Progesterone for the Treatment of Traumatic Brain Injury III (ProTECT)

David Wright

Status and phase: Terminated; Phase 3

Conditions: Traumatic Brain Injury

Treatments: Drug: Placebo; Drug: Progesterone

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00822900

1RO1 NS062778-01

IRB00014409

Details and patient eligibility

About

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.

Enrollment: 882 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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882 participants in 2 patient groups, including a placebo group

Progesterone

Experimental group

Description:

Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone) 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 72 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 will be combined with a 20% Intralipid mixture for infusion.

Treatment:

Drug: Progesterone

Placebo

Placebo Comparator group

Description:

Placebo stock solution was the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid was based on the same mg/kg/hr volume that would be required if PROG had been in the vial. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid was administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table was used by the on-sight pharmacy to mix the correct "dose" for a 10 cc/hour continuous infusion over the 72 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 placebo will be combined with a 20% Intralipid mixture for infusion.

Treatment:

Drug: Placebo