Study Overview

Traumatic Brain Injury (TBI) is a condition, not a one-time event. Effective treatment of TBI represents a great unmet need in public health. In 2013, approximately 2.8 million TBI-related emergency department (ED) visits, hospitalizations, and deaths occurred in the United States. TBI is a contributing factor in a third of all injury-related US deaths. An estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and psychological health disabilities of TBI, with annual direct and indirect costs estimated at over $76 billion. Although we are gaining ground in our understanding of the pathophysiology of TBI, these advances have failed to translate into a single successful clinical trial or treatment.

The NINDS-funded, multicenter (TRACK-TBI) study aims to change this. In collaboration with expert public-private partners, we collected detailed clinical data on subjects presenting at 18 U.S. sites, across the injury spectrum, along with CT/MRI imaging, blood biospecimens, and detailed clinical outcomes. TRACK-TBI has enrolled 2697 acute adult and pediatric TBI subjects; 299 orthopedic controls and 300 friend controls through the TED (TBI Endpoints Development) Initiative. This rich and diverse precision medicine dataset provides a global platform to connect TBI’s best scientists.

The specific aims of the TRACK-TBI and TED friend control studies are to:

1. Create a widely accessible, comprehensive TBI Information Commons that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers from subjects across the age and injury spectra, and provides analytic tools and resources to support TBI research.
2. Validate imaging, proteomic, and genetic biomarkers that will improve classification of TBI, permit appropriate selection and stratification of patients for clinical trials, and contribute to the development of a new taxonomy for TBI.
3. Evaluate a flexible outcome assessment battery comprised of a broad range of TBI common data elements that enables assessment of multiple outcome domains across all phases of recovery and at all levels of TBI severity.
4. Determine which tests, treatments, and services are effective and appropriate for which TBI patients, and use this evidence to recommend practices that offer the best value.
5. Create a healthy control subject population for the comparison of socioeconomic; imaging; biomarker; and outcomes data with the TRACK-TBI subjects.

More information is available on the TRACK-TBI and TED websites:
https://tracktbi.ucsf.edu/transforming-research-and-clinical-knowledge-tbi
https://tbiendpoints.ucsf.edu/