Monitoring biomarkers in traumatic brain injury treatment
The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)
This study is trying to see if tracking certain biological markers can help doctors find the best treatments for people with severe traumatic brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 11 sites (San Diego, California and 10 other locations) |
| Trial ID | NCT04855396 on ClinicalTrials.gov |
What this trial studies
This study focuses on identifying and monitoring biomarkers that can predict individual patient responses to treatments for severe traumatic brain injury (TBI). It involves collecting biospecimens such as serum, plasma, and cerebrospinal fluid (CSF) shortly after injury and at regular intervals to assess changes in biomarker levels. The goal is to improve the efficiency of clinical trials by enabling the selection of patients who are most likely to benefit from new therapeutic interventions. The study will utilize data from the HOBIT trial to correlate biomarker levels with clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have sustained a severe traumatic brain injury and are enrolled in the HOBIT trial.
Not a fit: Patients who are profoundly anemic or for whom blood samples cannot be obtained will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with severe traumatic brain injury.
How similar studies have performed: While the approach of using biomarkers in TBI is gaining traction, this specific study is part of a novel effort to enhance treatment personalization and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrolled in HOBIT (this is an ancillary study to the HOBIT Trial) Exclusion Criteria: * Profoundly anemic (subjects who are profoundly anemic require blood transfusion) * Blood samples cannot be obtained
Where this trial is running
San Diego, California and 10 other locations
- UCSD Medical Center - Hillcrest Hospital — San Diego, California, United States (Recruiting)
- St. Mary's Medical Center — West Palm Beach, Florida, United States (Recruiting)
- 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)
Study contacts
- Principal investigator: Frederick Korley, MD, PhD — University of Michigan
- Study coordinator: Natalie Fisher
- Email: brownnat@med.umich.edu
- Phone: 734-232-2012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.