An observational study in Spinal Cord Injuries, sponsored by University of California, San Francisco. Enrolling by invitation at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by University of California, San Francisco · Observational
The overall goal of Transforming Research and Clinical Knowledge in Spinal Cord Injury (TRACK-SCI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics of acute traumatic spinal cord injury (SCI). TRACK-SCI seeks to combine high quality care variables with high density physiology data collection to better understand diagnose, characterize, and track the temporal profile of recovery for SCI patients. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-SCI site with a spinal cord injury that meets eligibility criteria.
Spinal cord injury (SCI) is a major cause of morbidity worldwide with debilitating impacts on quality of life and the healthcare system. To date, a data-dense research registry specific to SCI remains to be constructed. To this end, the study will collect SCI data across five primary domains: 1) demographics and baseline history, 2) clinical course variables from the emergency department (ED) to the intensive care unit (ICU), 3) standard of care neuroimaging (CT and MRI) and intraoperative neuromonitoring, 4) blood and cerebrospinal fluid (CSF) samples for proteomic and genetic biomarkers, and 5) outcome measures of functional disability, mental health and quality of life at 3, 6, and 12 months. The investigators seek to correlate these high-density physiology data with baseline risk factors, imaging parameters, and biomarkers for a comprehensive approach to SCI diagnosis during acute care as well as prognosis across subacute and chronic phases of recovery -- in order to truly step toward the advancement of research and clinical knowledge in SCI.
The main objective is to provide a comprehensive prospective analysis of multiple variables in acute SCI that impact long-term outcomes. This is intended to provide a rich resource for asking key questions related to the optimization of treatment, and the planning and execution of pivotal clinical trials in SCI.
Core Hypotheses:
Specific Aims:
Aim 1. Diagnosis: Building a knowledge network for acute SCI. A detailed prospective study of critical care practices and outcomes for SCI patients admitted to TRACK-SCI sites will be conducted to build a knowledge network for acute SCI diagnostics.
Aim 2. Prognosis: Predictive models and biomarkers. The research team will develop multidimensional prognostic indicators for predicting outcomes and stratifying patients using detailed physiological, imaging, and genetic datasets.
Aim 3: Data analysis and sharing. The development of better predictors of outcome and methods for stratification will be advanced by allowing qualified access to our granular data. The availability to qualified users of the detailed acute 'diagnostic' dataset along with gene-expression data and functional outcomes at 6\&12 mos will leverage the project as a valuable international SCI community resource.
The investigators will enroll patients presenting to the Emergency Department with an acute SCI, in which the patient has sustained a traumatically induced disruption of spinal cord function, as manifested by one of the following: detection through clinical assessment of motor and/or sensory deficit from baseline, and/or radiologic evidence of cord signal disruption.
For trauma controls, investigators will recruit non-neurological traumatic injury patients from the ED. For healthy controls, investigators will recruit primarily friends and family members of SCI participants.
Exclusion Criteria:
Individuals recently admitted to hospital and diagnosed with acute, traumatic spinal cord injury.
Individuals recently admitted to hospital and diagnosed with an acute, traumatic injury that is not spinal cord injury.
Generally healthy individuals not recently diagnosed with an acute, traumatic injury (including spinal cord injury).
Gene expression level in number of messenger RiboNucleic Acid (mRNA) transcripts for all genes expressed in white blood cells
Obtained from a 4.0mL blood draw
Time frame: Baseline (healthy control group), or as close as possible to time of injury (SCI and trauma control group)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (SCI Only)
American Spinal Injury Association standard assessment for documentation of the level and severity of a spinal cord injury (SCI). The ISNCSCI yields a grade from A to D, wherein A indicates greater severity.
Time frame: From admission to 12 months post-injury
Plan to share: Yes — All data (de-identified) that underlie results in a publication will be made available to other researchers upon Executive Committee approval. Select de-identified datasets will be made publicly available via the Open Data Commons for Spinal Cord Injury (ODC-SCI), accessible at \<https://scicrunch.org/odc-sci\>.
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University of California, San Francisco