# Hyperbaric Oxygen BrainInjury Treatment (HOBIT) Trial-SDMC Supplement FITBIR

> **NIH NIH U01** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2022 · $96,424

## Abstract

PROJECT ABSTRACT / SUMMARY
Traumatic brain injury (TBI) is a devastating condition which continues to exert an overarching
problem of high mortality and poor outcomes on those with this condition. Preclinical and clinical
investigations strongly indicate that HBO2 is physiologically active in reducing brain injury and
improving outcomes in severe TBI. However, prior to a definitive efficacy study, important
information is required regarding optimizing the HBO2 treatment paradigm instituted in terms of
pressure and frequency of HBO2 treatments and whether NBH enhances the clinical
effectiveness of the HBO2 treatment. Based upon this promising evidence, the proposed
project will be a randomized, prospective, multicenter, adaptive dose-finding clinical trial
investigating the use of HBO2 treatment for patients with severe TBI. The primary objective will
be to determine the most effective hyperoxia dose schedule without producing oxygen toxicity
and clinical complications. Based on the sliding dichotomized GOS, the study aims to select the
combination of treatment parameters (pressure and intervening NBH) that is most likely to
demonstrate improvement at 6 months. Secondly, the trial also aims to determine whether
there is a > 50% probability of hyperoxia treatment demonstrating improvement in the rate of
good neurological outcome versus control in a subsequent confirmatory trial; and to inform
decisions on proceeding to, and optimizing a subsequent confirmatory trial. The trial will be
conducted in the Neurological Emergencies Treatment Trials network. This project is being
submitted as two bundled grant applications for the Clinical Coordinating Center (at the
University of Minnesota and the University of Michigan) and the Statistical and Data
Management Center (at the Medical University of South Carolina).

## Key facts

- **NIH application ID:** 10607604
- **Project number:** 3U01NS095814-05S1
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** Renee Hebert Martin
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $96,424
- **Award type:** 3
- **Project period:** 2021-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10607604

## Citation

> US National Institutes of Health, RePORTER application 10607604, Hyperbaric Oxygen BrainInjury Treatment (HOBIT) Trial-SDMC Supplement FITBIR (3U01NS095814-05S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10607604. Licensed CC0.

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