Monitoring biomarkers in traumatic brain injury treatment
Official title: The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)
Run by University of Michigan · NCT04855396 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 16 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 11 sites (San Diego, California and 10 other locations) |
| Status | Recruiting |
| Started | January 19, 2021 |
| Main results expected | July 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT04855396 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals who have sustained a severe traumatic brain injury and are enrolled in the HOBIT trial.
✕Probably not a fit
Patients who are profoundly anemic or for whom blood samples cannot be obtained will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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UCSD Medical Center - Hillcrest Hospital
San Diego, California, 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
Show 5 more locations
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St. Mary's Medical Center
West Palm Beach, Florida, United States Suspended -
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PIONEER-Prognosis: Using biomarkers and wearables to forecast recovery after mild traumatic brain injury
This study tests whether blood biomarkers, health data from records, and wearables can help predict how people recover after a mild traumatic brain injury treated in the emergency department.
-
HBOT to see if it helps cognition and well‑being in first responders with prior brain injury
This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.
-
Depth Electrode Monitoring after Traumatic Brain Injury
This study tests adding a depth electrode with continuous brain monitoring during external ventricular drain placement in adults with traumatic brain injury to see if cortical reverberation signals can be tracked safely.
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Understanding growth hormone deficiency after a brain injury in adults
This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.
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Electrical stimulation-assisted exercise for people with lower limb paralysis
This study tests whether adding electrical stimulation during exercise can improve leg muscle strength and endurance for people with paralysis.
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ZEPU-2000 robotic rehab for arm and leg weakness
This trial tests whether adding ZEPU-2000A, ZEPU-2000D, and ZEPU-2000E robotic rehabilitation to usual therapy helps adults with arm/leg movement problems from stroke, incomplete SCI, TBI, or related conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.