Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury (BIO-ProTECT)

Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)

Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury

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.

• Study Type: Observational
• Enrollment (Actual): 576

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Integrated Health System
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Health Center
    • Phoenix, Arizona, United States, 85251
      • Scottsdale Healthcare
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Medical Center
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital
    • San Jose, California, United States, 95128
      • Santa Clara Valley Medical Center
    • San Jose, California, United States, 95116
      • Regional Medical Ctr.-San Jose
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Shock Trauma
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48235
      • Sinai Grace Hospital
    • Detroit, Michigan, United States, 48201
      • Detroit Receiving
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Hospital
    • St. Paul, Minnesota, United States, 55101
      • Regions Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • St. Johns Mercy Medical Center
  • New York
    • New York, New York, United States, 10032
      • NYP Columbia
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Lukes Hospital
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University
    • Philadelphia, Pennsylvania, United States, 19102
      • Hahnemann University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Regional Medical Center/Elvis Presley Memorial Trauma Center
  • Texas
    • Austin, Texas, United States, 78752
      • Brackenridge Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • San Antonio, Texas, United States, 78234
      • Brooke Army Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froederdt Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
On progesterone treatment; The group assigned to progesterone treatment.
group assigned to placebo; The group that will not be receiving progesterone treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.	Blood will be collected/processed at baseline, 24 hours and 48 hours.	Baseline, 24 hours, 48 hours

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Michael Frankel, MD, Emory University

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: traumatic brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: IRB00014409a; 1R01NS071867 (U.S. NIH Grant/Contract)