Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT01730443
- Lead Sponsor
- Emory University
- Brief Summary
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.
- Detailed Description
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study just prior to the initiation of the study drug infusion and 24 and 48 hours from the time they are enrolled in the study to test for biomarkers that may help predict how severe the injury is and how well they improve. The investigators will also test to see if the study medication is being absorbed and is staying at a consistent level in the blood stream.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 576
- Moderate to severe brain injury (iGCS 12-4 or motor response 2-5 if intubated).
- 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 -
- Non-survivable injury as determined by treating
- 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 -
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured. Baseline, 24 hours, 48 hours Blood will be collected/processed at baseline, 24 hours and 48 hours.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Banner Good Samaritan Health Center
🇺🇸Phoenix, Arizona, United States
Maricopa Integrated Health System
🇺🇸Phoenix, Arizona, United States
University of Maryland Shock Trauma
🇺🇸Baltimore, Maryland, United States
University of Arizona
🇺🇸Tucson, Arizona, 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
Hurley Medical Center
🇺🇸Flint, Michigan, United States
University of Kentucky Hospital
🇺🇸Lexington, Kentucky, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Detroit Receiving
🇺🇸Detroit, Michigan, United States
Beaumont Health System
🇺🇸Royal Oak, Michigan, United States
Regions Medical Center
🇺🇸St. Paul, Minnesota, United States
North Memorial Hospital
🇺🇸Robbinsdale, Minnesota, United States
NYP Columbia
🇺🇸New York, New York, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Jefferson Hospital
🇺🇸Philadelphia, Pennsylvania, United States
St. Johns Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Brackenridge Hospital
🇺🇸Austin, Texas, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
St. Lukes Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Regional Medical Center/Elvis Presley Memorial Trauma Center
🇺🇸Memphis, Tennessee, United States
Froederdt Memorial Hospital
🇺🇸Milwaukee, Wisconsin, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Virginia Commonwealth
🇺🇸Richmond, Virginia, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
University Hospital
🇺🇸Cincinnati, Ohio, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States
Sinai Grace Hospital
🇺🇸Detroit, Michigan, United States
Scottsdale Healthcare
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Stanford Medical Center
🇺🇸Palo Alto, California, United States