Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury
NCT ID: NCT01730443
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
576 participants
OBSERVATIONAL
2011-07-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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On progesterone treatment
The group assigned to progesterone treatment.
No interventions assigned to this group
group assigned to placebo
The group that will not be receiving progesterone treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years (or developmental stage Tanner 5 in patients where age is not known)
* Blunt, traumatic, closed head injury (altered mental status due to brain injury)
* Able to initiate study drug infusion within 4 hours from time of injury -
Exclusion Criteria
* Bilateral dilated unresponsive pupils
* Spinal cord injury with neurological deficits, pre-injury paralysis (quad/paraplegic)
* Inability to perform activities of daily living (ADL) without assistance
* Cardiopulmonary arrest
* Status epilepticus on arrival or concern for post ictal state
* systolic blood pressure \< 90 for two consecutive readings at least 5 minutes apart any time prior to randomization
* O2 Sat \< 90 for at least 5 consecutive minutes any time prior to randomization
* Prisoner or ward of state
* Known active breast or reproductive organ cancers (via medical records or family interview)
* Known allergy to progesterone or Intralipid components (egg yolk) (via medical records or family interview)
* Known history of blood clotting disorder (Protein S or C deficiency, etc.) or history of pulmonary embolism (via medical records or family interview) or active/ongoing thromboembolic event (myocardial infarction, ischemic stroke, pulmonary embolism, deep vein thrombosis).
* Blood or serum ethanol (EtOH) ≥ 250 mg %
* Positive qualitative urine or serum pregnancy test
* Concern for inability to follow up at 6 months (residence in foreign country, homeless with limited contacts,
* undocumented immigrants, or high likelihood of becoming incarcerated during study period, etc.)
* Patient in Opt Out registry or wearing Opt Out bracelet -
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Emory University
OTHER
Responsible Party
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Michael Frankel
Professor
Principal Investigators
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Michael Frankel, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Banner Good Samaritan Health Center
Phoenix, Arizona, United States
Maricopa Integrated Health System
Phoenix, Arizona, United States
Scottsdale Healthcare
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Stanford Medical Center
Palo Alto, California, United States
San Francisco General Hospital
San Francisco, California, United States
Regional Medical Ctr.-San Jose
San Jose, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
University of Maryland Shock Trauma
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Detroit Receiving
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 Health System
Royal Oak, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Hospital
Robbinsdale, Minnesota, United States
Regions Medical Center
Saint Paul, Minnesota, United States
St. Johns Mercy Medical Center
St Louis, Missouri, United States
NYP Columbia
New York, New York, United States
University Hospital
Cincinnati, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
St. Lukes Hospital
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Jefferson Hospital
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Regional Medical Center/Elvis Presley Memorial Trauma Center
Memphis, Tennessee, United States
Brackenridge Hospital
Austin, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Virginia Commonwealth
Richmond, Virginia, United States
Froederdt Memorial Hospital
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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IRB00014409a
Identifier Type: -
Identifier Source: org_study_id