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Blood Tests to Study Injury Severity and Outcome in Traumatic Brain Injury Patients (BioProTECT)

This study is currently recruiting participants.
Verified May 2013 by Emory University
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
David Wright, Emory University
ClinicalTrials.gov Identifier:
NCT01730443
First received: July 26, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomarkers of Injury and Outcome in ProTECT III

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 855
Study Start Date: July 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
On progesterone treatment
The group assigned to progesterone treatment.
group assigned to placebo
The group that will not be receiving progesterone treatment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730443

Contacts
Contact: David W Wright, MD 404-778-1709 david.wright@emory.edu
Contact: Rie Calcaterra 404-778-1713 acalc01@emory.edu

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

No publications provided

Responsible Party: David Wright, Assoc. Professor, Emergency Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01730443     History of Changes
Other Study ID Numbers: 14409, 1R01NS071867
Study First Received: July 26, 2011
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Emory University:
traumatic brain injury

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

ClinicalTrials.gov processed this record on May 21, 2013