Clinical trial NCT01730443: Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury
Official title: Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2012-11-21
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with a moderate to severe blunt traumatic brain injury who meet the inclusion and exclusion criteria for the ProTECT III study.

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.

Eligibility criteria: Inclusion Criteria:

* 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 -

Exclusion Criteria:

* 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 -

Primary outcomes:
measure: serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.
timeFrame: Baseline, 24 hours, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Health Center
state: Arizona
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
city: Phoenix
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Palo Alto
country: United States
facility: Stanford Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Jose
country: United States
facility: Regional Medical Ctr.-San Jose
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Shock Trauma
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Detroit
country: United States
facility: Detroit Receiving
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Hospital
state: Minnesota
city: St. Paul
country: United States
facility: Regions Medical Center
state: Minnesota
city: St. Louis
country: United States
facility: St. Johns Mercy Medical Center
state: Missouri
city: New York
country: United States
facility: NYP Columbia
state: New York
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Bethlehem
country: United States
facility: St. Lukes Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Memphis
country: United States
facility: Regional Medical Center/Elvis Presley Memorial Trauma Center
state: Tennessee
city: Austin
country: United States
facility: Brackenridge Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth
state: Virginia
city: Milwaukee
country: United States
facility: Froederdt Memorial Hospital
state: Wisconsin
Study officials:
affiliation: Emory University
name: Michael Frankel, MD
role: PRINCIPAL_INVESTIGATOR
References: