Condition: Traumatic Brain Injury · Sponsor: University of Michigan
There are no therapeutic agents that have been shown to improve outcomes from severe traumatic brain injury (TBI). Critical barriers to progress in developing treatments for severe TBI are the lack of: 1) monitoring biomarkers for assessing individual patient response to treatment; 2) predictive biomarkers for identifying patients likely to benefit from a promising intervention. Currently, clinical examination remains the fundamental tool for monitoring severe TBI patients and for subject selection in clinical trials. However, these patients are typically intubated and sedated, limiting the utility of clinical examinations. Validated monitoring and predictive biomarkers will allow titration of the dose of promising therapeutics to individual subject response, as well as make clinical trials more efficient by enabling the enrollment of subjects likely to benefit. Glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL) and high sensitivity c-reactive protein (hsCRP) are promising biomarkers that may be useful as 1) monitoring biomarkers; 2) predictive biomarkers in severe TBI trials. Although the biological rationale supporting their use is strong, significant knowledge gaps remain. To address these gaps in knowledge, we propose an ancillary observational study leveraging an ongoing severe TBI clinical trial that is not funded to collect biospecimen. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial that …
This description comes directly from the study's public registry record.
Natalie Fisher · 734-232-2012 · brownnat@med.umich.edu
Frederick Korley, MD, PhD · 734-647-0261 · korley@med.umich.edu
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| UCSD Medical Center - Hillcrest Hospital | San Diego, California, United States | Recruiting |
| St. Mary's Medical Center | West Palm Beach, Florida, United States | Suspended |
| University of Iowa Hospitals & Clinics | Iowa City, Iowa, United States | Recruiting |
| University of Kentucky Hospital | Lexington, Kentucky, United States | Recruiting |
| University of Maryland Medical Center | Baltimore, Maryland, United States | Recruiting |
| Detroit Receiving Hospital | Detroit, Michigan, United States | Recruiting |
| Hennepin County Medical Center | Minneapolis, Minnesota, United States | Recruiting |
| University of Nebraska Medical Center | Omaha, Nebraska, United States | Suspended |
| Duke University Hospital | Durham, North Carolina, United States | Not Yet Recruiting |
| OSU Wexner Medical Center | Columbus, Ohio, United States | Suspended |
| Hamilton General Hospital | Hamilton, Ontario, Canada | Suspended |
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Source record: clinicaltrials.gov/study/NCT04855396