TRACK-TBI Multicenter Initiative
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Grant No: RC2NS069409
Coordinating Center: University of California, San Francisco
The global aim of this proposal is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving field of these emerging technologies in TBI.
Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 Acute TBI Centers and 1 Rehabilitation Center:
UCSF, San Francisco General Hospital
Geoffrey Manley, MD, PhD
University of Pittsburgh Medical Center
David Okonkwo, MD, PhD
University Medical Center Brackenridge
Alex Valadka, MD
Mount Sinai Rehabilitation Center
Wayne Gordon, PhD
- Presentation to emergency department < 24 hours post-injury
- Head CT scan for TBI as part of regular care
- English speaking (outcome measures have not been normed for non-English)
Study Components (Ref: NIH-NINDS TBI Common Data Elements):
1. Clinical care, demographic and outcome data collection.
2. Blood draws for proteomic and genetic marker analyses.
3. 3T Magnetic Resonance Imaging will be completed on a subset of patients able to return 1-2 weeks post-injury.
4. Three month follow up. The Glasgow Outcome Scale - Extended (GOS-E) and neurological symptoms inventory will be administered to patients over the phone 3 months post-injury.
5. Six, twelve and twenty-four month neurocognitive assessments. Standardized measures from all designated CORE domains for outcome after TBI by the CDEs which include:
- Global recovery
- Functional outcome
- Psychological impairment
- Post-traumatic stress disorder (PTSD)
- Quality of life
Detailed Study Protocol at ClinicalTrials.gov: NCT01565551
NIH-NINDS Common Data Elements for Traumatic Brain Injury
For more information contact:
John Yue, CCRC
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