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

Sponsor
Emory University (Other)
Overall Status
Terminated
CT.gov ID
NCT01730443
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
576
Enrollment
37
Locations
36
Duration (Months)
15.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    576 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)
    Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    On progesterone treatment

    The group assigned to progesterone treatment.
    group assigned to placebo

    The group that will not be receiving progesterone treatment

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Good Samaritan Health Center Phoenix Arizona United States 85006
    2 Maricopa Integrated Health System Phoenix Arizona United States 85008
    3 Scottsdale Healthcare Phoenix Arizona United States 85251
    4 University of Arizona Tucson Arizona United States 85724
    5 Stanford Medical Center Palo Alto California United States 94305
    6 San Francisco General Hospital San Francisco California United States 94110
    7 Regional Medical Ctr.-San Jose San Jose California United States 95116
    8 Santa Clara Valley Medical Center San Jose California United States 95128
    9 Grady Memorial Hospital Atlanta Georgia United States 30303
    10 University of Kentucky Hospital Lexington Kentucky United States 40536
    11 University of Maryland Shock Trauma Baltimore Maryland United States 21201
    12 Johns Hopkins Baltimore Maryland United States 21287
    13 Detroit Receiving Detroit Michigan United States 48201
    14 Henry Ford Hospital Detroit Michigan United States 48202
    15 Sinai Grace Hospital Detroit Michigan United States 48235
    16 Hurley Medical Center Flint Michigan United States 48503
    17 Beaumont Health System Royal Oak Michigan United States 48073
    18 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    19 North Memorial Hospital Robbinsdale Minnesota United States 55422
    20 Regions Medical Center St. Paul Minnesota United States 55101
    21 St. Johns Mercy Medical Center St. Louis Missouri United States 63141
    22 NYP Columbia New York New York United States 10032
    23 University Hospital Cincinnati Ohio United States 45267
    24 Oregon Health Sciences University Portland Oregon United States 97239
    25 St. Lukes Hospital Bethlehem Pennsylvania United States 18015
    26 Geisinger Medical Center Danville Pennsylvania United States 17822
    27 Penn State Hershey Medical Center Hershey Pennsylvania United States 17033
    28 Hahnemann University Hospital Philadelphia Pennsylvania United States 19102
    29 University of Pennsylvania Hospital Philadelphia Pennsylvania United States 19104
    30 Jefferson Hospital Philadelphia Pennsylvania United States 19107
    31 Temple University Philadelphia Pennsylvania United States 19122
    32 Regional Medical Center/Elvis Presley Memorial Trauma Center Memphis Tennessee United States 38103
    33 Brackenridge Hospital Austin Texas United States 78752
    34 Memorial Hermann Hospital Houston Texas United States 77030
    35 Brooke Army Medical Center San Antonio Texas United States 78234
    36 Virginia Commonwealth Richmond Virginia United States 23298
    37 Froederdt Memorial Hospital Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Emory University
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Michael Frankel, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Frankel, Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT01730443
    Other Study ID Numbers:
    • IRB00014409a
    • 1R01NS071867
    First Posted:
    Nov 21, 2012
    Last Update Posted:
    Dec 4, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Michael Frankel, Professor, Emory University
    traumatic brain injury
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries

    Study Results

    No Results Posted as of Dec 4, 2014