TRACK-TBI Precision Medicine Phase 2-Option I
University of California, San Francisco
Summary
This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. The study team will enroll a cohort of moderate to severe TBI subjects (N=50), stratified according to VA/DoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling. Subjects will be assessed over 3 months.
Description
In 2009, the multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury Consortium was implemented to characterize the clinical, magnetic resonance imaging (MRI), and blood-based biomarker features of TBI to inform design of next-generation precision medicine clinical trials in TBI. Over the past 10+ years, TRACK-TBI has been supported by National Institute of Neurological Disorders and Stroke (NINDS), Department of Defense (DoD), Department of Energy (DoE), the National Football League, and other philanthropic and industry partners. TRACK-TBI has enrolled \>3000 contro…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 - 65y inclusive * History or evidence of TBI, according to DoD-VA criteria * Glasgow Coma Scale (GCS) 3 - 15 after resuscitation in the ED * Head CT with evidence of trauma-related abnormality (except for isolated epidural hematoma (EDH)) * Ability to undergo MRI within 48 hours of injury * Ability to obtain informed consent from participant or Legally Authorized Representative (LAR) within 6 hours of injury * Fluency in English or Spanish Exclusion Criteria: * Unstable respiratory or hemodynamic status * Evidence of penetrating brain injury * Isolated EDH as on…
Locations (5)
- University of California, San FranciscoSan Francisco, California
- University of Pennsylvania/Penn Presbyterian Medical CenterPhiladelphia, Pennsylvania
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- University of UtahSalt Lake City, Utah
- Medical College of WisconsinMilwaukee, Wisconsin