A national repository of biological samples from patients who have sustained traumatic brain injuries (TBIs) has been established in the Department of Neurological Surgery at the University of Pittsburgh. This biorepository supports the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study, a multi-center initiative funded by the National Institutes of Health (NIH) that is intended to revolutionize clinical care for brain-injured patients. A central goal of the TRACK-TBI biorepository is to identify blood-based biomarkers that can assist hospital-based clinicians in diagnosing TBIs and allow industry partners in the laboratory to identify new, effective treatments. Three thousand participants who have sustained a TBI are being recruited into the TRACK-TBI study, and a large, high-quality database of clinical, imaging, biomarker, and outcome data is being generated.
In collaboration with the TRACK-TBI coordinating center at the University of California San Francisco (led by Geoff Manley, MD) and our 17 U.S. partner sites, David Okonkwo, MD, PhD, and Ava Puccio, RN, PhD, at the University of Pittsburgh recently received a large supplemental award from the U.S. Department of Defense to establish the TRACK-TBI biorepository. Following laboratory renovations and certification in February 2016, the Department of Neurological Surgery at the University of Pittsburgh became the official new home of the TRACK-TBI biospecimens repository.
The TRACK-TBI biorepository is already the largest centralized collection of biological samples from TBI patients in the US. For a complex disorder like TBI, which has global incidence but lacks definitive clinical classification for diagnosis and therapy, multicenter collaboration is key for progress in research. Only with large numbers of patients and samples will researchers be able to address the many variations of TBIs. Similar to other disease processes, such as cardiovascular disease and cancer, diagnoses must be matched with a biomarker of injury and genetic markers for treatment directives.
“Front-Runner” Biomarkers for Diagnoses
Our partnership with the TRACK-TBI effort has already borne fruit, with an early indication from the pilot work on a biomarker of interest, glial fibrillary acidic protein (GFAP), a brain-specific protein released into serum as a pathophysiological response to TBI. Based on the initial TRACK-TBI sample set (215 patients), the measurement of GFAP in blood has been shown to be effective in identifying patients with a high likelihood of having abnormal pathology seen on a CT scan, and was recently approved by the FDA for clinical use in identifying patients unlikely to have lesions on head CT when measured in serum in the acute phase after injury. Other biomarkers of interest, now undergoing further study, include ubiquitin C-terminal hydrolase L1 (UCHL-1) and neuroinflammatory markers.
Through the support of the NIH and the Department of Defense, and in partnership with the national TRACK-TBI study, investigators at the University of Pittsburgh Department of Neurological Surgery are generating an international resource statistically powered to validate new, clinically relevant TBI biomarkers.