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Progesterone for the Treatment of Traumatic Brain Injury III

NCT00822900·36 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

David Wright

With

Medical University of South Carolina
Neurological Emergencies Treatment Trials Network (NETT)

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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

The record

StatusTerminated

PhasePhase 3

Taking part882

StartedMar 2010

UpdatedJan 20, 2016

Conditions

Traumatic Brain Injury

Where36

Maricopa Integrated Health System
Phoenix, Arizona, United States
Banner Good Samaritan
Phoenix, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States

Clareo Health | Progesterone for the Treatment of Traumatic Brain Injury III