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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01730443
Recruitment Status : Terminated (Parent trial (ProTECT III) stopped for futility)
First Posted : November 21, 2012
Last Update Posted : December 4, 2014
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael Frankel, Emory University

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

Condition or disease
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
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 : July 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

On progesterone treatment
The group assigned to progesterone treatment.
group assigned to placebo
The group that will not be receiving progesterone treatment

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. [ Time Frame: Baseline, 24 hours, 48 hours ]
    Blood will be collected/processed at baseline, 24 hours and 48 hours.

Biospecimen Retention:   Samples Without DNA
with consent there will be long term storage of serum for Non-DNA testing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01730443

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

Responsible Party: Michael Frankel, Professor, Emory University Identifier: NCT01730443     History of Changes
Other Study ID Numbers: IRB00014409a
1R01NS071867 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Michael Frankel, Emory University:
traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs