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Progesterone for the Treatment of Traumatic Brain Injury III

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury

Intervention: Progesterone (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: David Wright

Official(s) and/or principal investigator(s):
David W Wright, MD, Principal Investigator, Affiliation: Emory University


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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)

Secondary outcome:


Disability Rating Scale

Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis

Potentially Associated Adverse Events: Pulmonary Embolism

Potentially Associated Adverse Events: Acute Ischemic Stroke

Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)

Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level

Potentially Associated Adverse Events: Sepsis

Potentially Associated Adverse Events: Pneumonia

Potentially Associated Adverse Events: Central Nervous System (CNS) Infection

Potentially Associated Adverse Events: Myocardial Infarction (MI)


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


- 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

Locations and Contacts

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

Additional Information

Starting date: March 2010
Last updated: June 24, 2015

Page last updated: August 23, 2015

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