Progesterone for the Treatment of Traumatic Brain Injury III

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00822900

Run by

David Wright

People needed

882

Starts

2010-03-01

Expected to finish

2014-07-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Maricopa Integrated Health System — Phoenix, Arizona, United States
• Banner Good Samaritan — Phoenix, Arizona, United States
• Scottsdale Healthcare — Scottsdale, Arizona, United States
• University of Arizona Medical Center — Tuscon, Arizona, United States
• Santa Clara Valley Hospital — Palo Alto, California, United States
• Stanford Medical Center — Palo Alto, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• Regional Medical Center-San Jose — San Jose, California, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• University of Maryland Shock Trauma — Baltimore, Maryland, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Sinai Grace Hospital — Detroit, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• Beaumont Royal Oak Hospital — Royal Oak, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• North Memorial Hospital — Robbinsdale, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• St. Johns Mercy Medical Center — St Louis, Missouri, United States
• Columbia New York Presbyterian Hospital — New York, New York, United States
• University Hospital — Cincinnatti, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• St. Luke's Hospital — Bethlehem, Pennsylvania, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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