We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01730443
Recruitment Status : Terminated (Parent trial (ProTECT III) stopped for futility)
First Posted : November 21, 2012
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):

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
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 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 : July 2011
Primary Completion Date : May 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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. [ 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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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 -
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01730443

  Show 37 Study Locations
Sponsors and Collaborators
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Michael Frankel, MD Emory University
More Information

Responsible Party: Michael Frankel, Professor, Emory University
ClinicalTrials.gov 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