Progesterone for the Treatment of Traumatic Brain Injury III
| Status: | Terminated |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | July 2014 |
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.
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.
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.
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
We found this trial at
36
sites
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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