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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Wright, Emory University
ClinicalTrials.gov Identifier:
NCT01730443
First received: July 26, 2011
Last updated: November 14, 2013
Last verified: November 2013

July 26, 2011
November 14, 2013
July 2011
July 2014   (final data collection date for primary outcome measure)
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.
  • serum biomarkers of structural brain injury (S100B, GFAP, UCH-L1, SBDP150)will be measured. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Blood will be collected/processed at baseline prior to study drug infusion
  • serum biomarkers of structural brain injury (S100B, GFAP, UCH-L1, SBDP150)will be measured. [ Time Frame: 24 hrs from randomization ] [ Designated as safety issue: No ]
    Blood will be collected/processed 24 hrs from time of randomization.
  • serum biomarkers of structural brain injury (S100B, GFAP, UCH-L1, SBDP150)will be measured. [ Time Frame: 48 hours from randomization ] [ Designated as safety issue: No ]
    Blood will be collected/processed 48 hours from time of randomization.
Complete list of historical versions of study NCT01730443 on ClinicalTrials.gov Archive Site
Not Provided
  • Progesterone levels will be measured. [ Time Frame: 24 hrs from randomization ] [ Designated as safety issue: No ]
    Blood will be collected/processed 24 from randomization to test progesterone PK levels.
  • Progesterone levels will be measured. [ Time Frame: 48 hrs from randomization ] [ Designated as safety issue: No ]
    Blood will be collected/processed 48 hrs from randomization to test PK levels of progesterone.
Not Provided
Not Provided
 
Blood Tests to Study Injury Severity and Outcome in Traumatic Brain Injury Patients
Biomarkers of Injury and Outcome in ProTECT III

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

with consent there will be long term storage of serum for Non-DNA testing

Probability Sample

patients with a moderate to severe blunt traumatic brain injury who meet the inclusion and exclusion criteria for the ProTECT III study.

Traumatic Brain Injury
Not Provided
  • On progesterone treatment
    The group assigned to progesterone treatment.
  • group assigned to placebo
    The group that will not be receiving progesterone treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
855
January 2015
July 2014   (final data collection date for primary outcome measure)

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 -
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01730443
IRB00014409a, 1R01NS071867
Yes
David Wright, Emory University
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Michael Frankel, MD Emory University
Principal Investigator: David W Wright, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP