# Biomarkers in the Hyperbaric Oxygen in Brain Injury Treatment Trial

> **NIH NIH R01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $51,999

## Abstract

Project Summary / Abstract
Traumatic Brain Injury (TBI) is a major cause of death and disability both in the United States and worldwide.
This proposal focuses on persons with severe TBI (those with prolonged unresponsiveness [Glasgow Coma
Scale < 8]). Severe TBI affects nearly 27,000 persons in the United States each year. These patients
experience high mortality and require sophisticated care in intensive care units estimated at up to $244 billion
dollars each year. 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 seeks to determine the dose of
hyperbaric oxygen therapy (HBOT) that that has the highest likelihood of demonstrating efficacy in a phase III
trial. The proposed study will: 1) validate the accuracy of candidate monitoring biomarkers for predicting clinical
outcome; 2) determine the treatment effect of different doses of HBOT on candidate monitoring biomarkers;
and 3) determine whether there is a biomarker defined subset of severe TBI that responds favorably to HBOT.
This proposal will: 1) inform a go/no-go decision for a phase III trial of HBOT by providing adjunctive evidence
of the effect of HBOT on key biological pathways through which HBOT is hypothesized to affect outcome; 2)
provide evidence to support further study of the first monitoring biomarkers of severe TBI; 3) increase the
likelihood of success of a phase III trial by identifying the sub-population of severe TBI likely to benefit from
HBOT; 4) create a repository of TBI biospecimen which may be accessed by other investigators.

## Key facts

- **NIH application ID:** 10689546
- **Project number:** 3R01NS114251-03S1
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Frederick Kofi Korley
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $51,999
- **Award type:** 3
- **Project period:** 2020-09-15 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10689546

## Citation

> US National Institutes of Health, RePORTER application 10689546, Biomarkers in the Hyperbaric Oxygen in Brain Injury Treatment Trial (3R01NS114251-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10689546. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*