Hyperbaric Oxygen Brain Injury Treatment Trial (HOBIT)

May 22, 2026 updated by: Gaylan Rockswold

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preclinical and clinical investigations strongly indicate that hyperbaric oxygen (HBO2) is physiologically active in improving the destructive processes in severe Traumatic Brain Injury (TBI). However, prior to a definitive efficacy study, important information is required regarding optimizing the HBO2 treatment paradigm instituted in terms of pressure and whether NBH enhances the clinical effectiveness of the HBO2 treatment. Preclinical investigators working with TBI models have used pressures varying from 1.5 to 3.0 atmospheres absolute (ATA). Clinical investigators have used pressure varying from 1.5 to 2.5 ATA. However, the lungs in severe TBI patients have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to oxygen (O2) toxicity. Working within these constraints, it is essential to determine the most effective HBO2 treatment parameters without producing O2 toxicity and clinical complications. This proposed clinical trial is designed to answer these questions and to provide important data to plan a definitive efficacy trial.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Completed
        • Hamilton Heath Services
  • United States
    • California
      • San Diego, California, United States, 92103
        • Recruiting
        • UCSD Medical Center - Hillcrest Hospital
        • Contact:
        • Principal Investigator:
          • Jessica Weaver, MD
    • Florida
      • West Palm Beach, Florida, United States, 33407
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Nicholas Mohr, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Hospital
        • Principal Investigator:
          • David Dornbos, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
        • Principal Investigator:
          • Kinjal Sethuraman, MD
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Detroit Receiving Hospital
        • Principal Investigator:
          • Anthony Lagina, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Hospital
        • Contact:
        • Principal Investigator:
          • Sam Cramer, MD, PhD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Completed
        • University of Nebraska Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Hospital
        • Contact:
        • Principal Investigator:
          • Katherine Colton, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Completed
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 16 years or older and 65 years or younger
  • Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8.
  • Marshall computerized tomography (CT) score >1 in patients with a GCS of 7 or 8 or patients with an alcohol level >200 mg/dl
  • Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy/craniectomy or any other major surgical procedure OR
  • Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy/craniectomy or major surgical procedure

Exclusion Criteria:

  • First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury
  • GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)
  • Penetrating head injury
  • Pregnant
  • Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits
  • Unstable acute spinal cord injury
  • Fixed coagulopathy
  • Severe hypoxia
  • Cardiopulmonary resuscitation performed
  • Coma suspected to de due to primarily non-TBI causes
  • Any contraindications to the study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric oxygen (1.5 ATA, no NBH)
Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Drug: Hyperbaric oxygen (1.5 ATA, no NBH)
HBO at 1.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
Other Names:
  • HBO
Experimental: Hyperbaric oxygen (2.0 ATA, no NBH)
Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Drug: Hyperbaric oxygen (2.0 ATA, no NBH)
HBO at 2.0 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
Other Names:
  • HBO
Experimental: Hyperbaric oxygen (2.5 ATA, no NBH)
Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.
Drug: Hyperbaric oxygen (2.5 ATA, no NBH)
HBO at 2.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
Other Names:
  • HBO
Experimental: Hyperbaric oxygen (1.5 ATA + NBH)
Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Drug: Hyperbaric oxygen (1.5 ATA + NBH)
HBO at 1.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
Other Names:
  • HBO
Experimental: Hyperbaric oxygen (2.0 ATA + NBH)
Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Drug: Hyperbaric oxygen (2.0 ATA + NBH)
HBO at 2.0 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
Other Names:
  • HBO
Experimental: Hyperbaric oxygen (2.5 ATA + NBH)
Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Drug: Hyperbaric oxygen (2.5 ATA + NBH)
HBO at 2.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
Other Names:
  • HBO
Experimental: Normobaric Hyperoxia (NBH)
Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
Drug: Normobaric Hyperoxia (NBH)
100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead
Other Names:
  • NBH
Active Comparator: Usual care
Usual care for severe TBI
Other: Usual Care
Will be treated with usual and customary care for severe traumatic brain injury
Other Names:
  • Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glasgow Outcome Scale Extended (GOS-E)
Time Frame: Assessment at 6 months
Assessment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of ICP elevation
Time Frame: First 5 days
The duration of ICP elevation will be measured using the area under the curve methodology
First 5 days
Therapeutic intensity level scores for controlling intracranial pressure (ICP)
Time Frame: First 5 days
This tracks the level of therapies used to control ICP during the first 5 days
First 5 days
Brain tissue partial pressure of oxygen
Time Frame: First 5 days
This outcome will be measured only in patients with LICOX monitoring
First 5 days
Serious adverse events
Time Frame: 180 days
Events resulting in death, a life-threatening adverse event, or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
180 days
Peak brain tissue oxygen (P02) during HBO treatments
Time Frame: First 5 days
To examine the association between peak brain tissue PO2 during hyperbaric treatment and favorable outcome at 6-months (measured by the GOS-E).
First 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaylan Rockswold

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
Strategies to Innovate EmeRgENcy Care Clinical Trials Network

Investigators

  • Principal Investigator: Gaylan L Rockswold, M.D., Ph.D., Hennepin County Medical Center, Minneapolis
  • Principal Investigator: Byron Gajewski, Ph.D., University of Kansas Medical Center
  • Principal Investigator: Frederick K Korley, M.D., Ph.D., University of Michigan
  • Principal Investigator: William Barsan, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Estimated)

October 26, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimated)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLR-NIH-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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