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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Banner Good Samaritan, Phoenix, Arizona, United States
Maricopa Integrated Health System, Phoenix, Arizona 85008, United States
Scottsdale Healthcare, Scottsdale, Arizona, United States
University of Arizona Medical Center, Tuscon, Arizona 85724, United States
Santa Clara Valley Hospital, Palo Alto, California 94304, United States
Stanford Medical Center, Palo Alto, California 94304, United States
San Francisco General Hospital, San Francisco, California 94110, United States
Regional Medical Center-San Jose, San Jose, California, United States
Grady Memorial Hospital, Atlanta, Georgia 30303, United States
University of Kentucky Medical Center, Lexington, Kentucky 40536, United States
University of Maryland Shock Trauma, Baltimore, Maryland 21201, United States
Detroit Receiving Hospital, Detroit, Michigan 48202, United States
Henry Ford Hospital, Detroit, Michigan 48202, United States
Sinai Grace Hospital, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan 48503, United States
Beaumont Royal Oak Hospital, Royal Oak, Michigan 48073, United States
Hennepin County Medical Center, Minneapolis, Minnesota 55414, United States
North Memorial Hospital, Robbinsdale, Minnesota, United States
Regions Hospital, St. Paul, Minnesota 55101, United States
St. Johns Mercy Medical Center, St. Louis, Missouri 63141, United States
Columbia New York Presbyterian Hospital, New York, New York 10032, United States
University Hospital, Cincinnatti, Ohio 45267, United States
Oregon Health Sciences University, Portland, Oregon 97239, United States
St. Luke's Hospital, Bethlehem, Pennsylvania 18017, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States
Hahnemann University Hospital, Philadelphia, Pennsylvania 19102, United States
Temple University Hospital, Philadelphia, Pennsylvania 19140, United States
Thomas Jefferson UniversityHospital, Philadelphia, Pennsylvania 19107, United States
University of Pennsylvania Hospital, Philadelphia, Pennsylvania 19104, United States
Regional Medical Center/Elvis Presley Memorial Trauma Center (The MED), Memphis, Tennessee, United States
Austin/Brackenridge, Austin, Texas 78752, United States
Memorial Hermann, Houston, Texas 77030, United States
Brooke Army Medical Center, San Antonio, Texas, United States
Virginia Commonwealth, Richmond, Virginia 23298, United States
Froedtert East Hospital, Milwaukee, Wisconsin 53226, United States