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Traumatic Brain InjuryPhase 2HOBITNCT02407028

Hyperbaric Oxygen Brain Injury Treatment Trial

A Phase 2 study testing Hyperbaric oxygen (1.5 ATA, no NBH), Hyperbaric oxygen (2.0 ATA, no NBH) and Hyperbaric oxygen (2.5 ATA, no NBH) in people with Traumatic Brain Injury, run by Gaylan Rockswold at 11 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Hyperbaric oxygen (1.5 ATA, no NBH), Hyperbaric oxygen (2.0 ATA, no NBH) and Hyperbaric oxygen (2.5 ATA, no NBH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
11 sitesin 2 countries
Study dates
25 Jun 2018to 30 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Fixed coagulopathy
  • Severe hypoxia
  • Cardiopulmonary resuscitation performed
  • Coma suspected to de due to primarily non-TBI causes
  • Any contraindications to the study intervention

Trial locations and contacts

11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gaylan L. Rockswold, M.D., Ph.D. contact

612-873-2810

gaylan.rockswold@hcmed.org

11 sites in 2 countries

United States10 sites, 8 recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Leslie Sult, lsult@som.umaryland.edu

    Kinjal Sethuraman, MD

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Completed

  • Detroit Receiving Hospital

    Detroit, Michigan, 48201

    Nick Wesner, nicholas.wesner@wayne.edu

    Anthony Lagina, MD

    Recruiting

  • Duke University Hospital

    Durham, North Carolina, 27710

    Tammy Hawley, tammy.hawley@duke.edu

    Katherine Colton, MD

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Catherine Fairfield, catherine-fairfield@uiowa.edu

    Nicholas Mohr, MD

    Recruiting

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536

    Ronda A PETREY, ronda.petrey@uky.edu

    David Dornbos, MD

    Recruiting

  • Hennepin County Hospital

    Minneapolis, Minnesota, 55415

    Jessica Gieseke, giese141@umn.edu

    Sam Cramer, MD, PhD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Completed

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California, 92103

    Lilian Von Husen, lvonhuse@health.ucsd.edu

    Jessica Weaver, MD

    Recruiting

  • St. Mary's Medical Center

    West Palm Beach, Florida, 33407

    Tracy RODRIGUEZ, Tracy.Rodriguez@tenethealth.com

    Faris Azar, MD

    Recruiting

Other trials in United States

Canada1 site

  • Hamilton Heath Services

    Hamilton, Ontario, L8L 2X2

    Completed

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Hyperbaric oxygen (1.5 ATA, no NBH), Hyperbaric oxygen (2.0 ATA, no NBH), Hyperbaric oxygen (2.5 ATA, no NBH), Hyperbaric oxygen (1.5 ATA + NBH), Hyperbaric oxygen (2.0 ATA + NBH)
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric oxygen (1.5 ATA, no NBH)Drug

    Also called HBO

    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

  • Hyperbaric oxygen (2.0 ATA, no NBH)Drug

    Also called HBO

    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

  • Hyperbaric oxygen (2.5 ATA, no NBH)Drug

    Also called HBO

    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

  • Hyperbaric oxygen (1.5 ATA + NBH)Drug

    Also called HBO

    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

  • Hyperbaric oxygen (2.0 ATA + NBH)Drug

    Also called HBO

    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

  • Hyperbaric oxygen (2.5 ATA + NBH)Drug

    Also called HBO

    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

  • Normobaric Hyperoxia (NBH)Drug

    Also called 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

  • Usual CareOther

    Also called Standard of Care

    Will be treated with usual and customary care for severe traumatic brain injury

Study groups in NCT02407028
Study groupRoleWhat they receive
Hyperbaric oxygen (1.5 ATA, no NBH)ExperimentalHyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Receives: Drug: Hyperbaric oxygen (1.5 ATA, no NBH)
Hyperbaric oxygen (2.0 ATA, no NBH)ExperimentalHyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Receives: Drug: Hyperbaric oxygen (2.0 ATA, no NBH)
Hyperbaric oxygen (2.5 ATA, no NBH)ExperimentalHyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.
Receives: Drug: Hyperbaric oxygen (2.5 ATA, no NBH)
Hyperbaric oxygen (1.5 ATA + NBH)ExperimentalHyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Receives: Drug: Hyperbaric oxygen (1.5 ATA + NBH)
Hyperbaric oxygen (2.0 ATA + NBH)ExperimentalHyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Receives: Drug: Hyperbaric oxygen (2.0 ATA + NBH)
Hyperbaric oxygen (2.5 ATA + NBH)ExperimentalHyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Receives: Drug: Hyperbaric oxygen (2.5 ATA + NBH)
Normobaric Hyperoxia (NBH)ExperimentalNormobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
Receives: Drug: Normobaric Hyperoxia (NBH)
Usual careActive comparatorUsual care for severe TBI
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glasgow Outcome Scale Extended (GOS-E)

    Measured: Assessment at 6 months

Secondary outcomes (5)

  1. Duration of ICP elevation

    The duration of ICP elevation will be measured using the area under the curve methodology

    Measured: First 5 days

  2. Therapeutic intensity level scores for controlling intracranial pressure (ICP)

    This tracks the level of therapies used to control ICP during the first 5 days

    Measured: First 5 days

  3. Brain tissue partial pressure of oxygen

    This outcome will be measured only in patients with LICOX monitoring

    Measured: First 5 days

  4. Serious adverse events

    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

    Measured: 180 days

  5. Peak brain tissue oxygen (P02) during HBO treatments

    To examine the association between peak brain tissue PO2 during hyperbaric treatment and favorable outcome at 6-months (measured by the GOS-E).

    Measured: First 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study start25 Jun 2018
  3. Primary completion26 Oct 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407028
Sponsor's protocol ID
GLR-NIH-2015
Acronym
HOBIT
Status last verified
Aug 2025
First submitted
18 Mar 2015
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rockswold SB, Rockswold GL, Zaun DA, Zhang X, Cerra CE, Bergman TA, Liu J. A prospective, randomized clinical trial to compare the effect of hyperbaric to normobaric hyperoxia on cerebral metabolism, intracranial pressure, and oxygen toxicity in severe traumatic brain injury. J Neurosurg. 2010 May;112(5):1080-94. doi: 10.3171/2009.7.JNS09363.

    PubMed 19852540

  • Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.

    PubMed 23510092

  • Rahman MM, Saif MSI, Beall J, Martin RL, Rockswold GL, Barsan WG, Korley FK, Silbergleit R, Stevenson V, Gajewski B. A Bayesian model with seasonal effects for predicting accrual in clinical trials: Application to HOBIT and BOOST-3 trials for severe traumatic brain injury. Contemp Clin Trials Commun. 2025 Dec 5;48:101586. doi: 10.1016/j.conctc.2025.101586. eCollection 2025 Dec.

    PubMed 41446562

  • Bantis LE, Young KJ, Tsimikas JV, Mosier BR, Gajewski B, Yeatts S, Martin RL, Barsan W, Silbergleit R, Rockswold G, Korley FK. Statistical assessment of the prognostic and the predictive value of biomarkers-A biomarker assessment framework with applications to traumatic brain injury biomarker studies. Res Methods Med Health Sci. 2023 Jan;4(1):34-48. doi: 10.1177/26320843221141056. Epub 2022 Dec 13.

    PubMed 37009524

  • Wang Y, Yeatts SD, Martin RH, Silbergleit R, Rockswold GL, Barsan WG, Korley FK, Rockswold S, Gajewski BJ. Selection of a statistical analysis method for the Glasgow Outcome Scale-Extended endpoint for estimating the probability of favorable outcome in future severe TBI clinical trials. Stat Med. 2023 Nov 10;42(25):4582-4601. doi: 10.1002/sim.9877. Epub 2023 Aug 20.

    PubMed 37599009

  • Beall J, Yeatts SD, Silbergleit R, Shutter L, Korley F, Gajewski B. Bayesian enrollment modeling for several emergency medicine clinical trials. Trials. 2025 Nov 10;26(1):483. doi: 10.1186/s13063-025-08748-3.

    PubMed 41214784

  • Shi X, Wick JA, Martin RL, Beall J, Silbergleit R, Rockswold GL, Barsan WG, Korley FK, Rockswold S, Gajewski BJ. Improved mortality analysis in early-phase dose-ranging clinical trials for emergency medical diseases using Bayesian time-to-event models with active comparators. Stat Med. 2024 Aug 30;43(19):3649-3663. doi: 10.1002/sim.10141. Epub 2024 Jun 17.

    PubMed 38885949

  • Yeatts SD, Martin RH, Meurer W, Silbergleit R, Rockswold GL, Barsan WG, Korley FK, Wright DW, Gajewski BJ. Sliding Scoring of the Glasgow Outcome Scale-Extended as Primary Outcome in Traumatic Brain Injury Trials. J Neurotrauma. 2020 Dec 15;37(24):2674-2679. doi: 10.1089/neu.2019.6969. Epub 2020 Aug 26.

    PubMed 32664792

  • Gajewski BJ, Meinzer C, Berry SM, Rockswold GL, Barsan WG, Korley FK, Martin RH. Bayesian hierarchical EMAX model for dose-response in early phase efficacy clinical trials. Stat Med. 2019 Jul 30;38(17):3123-3138. doi: 10.1002/sim.8167. Epub 2019 May 9.

    PubMed 31070807

  • Gajewski BJ, Berry SM, Barsan WG, Silbergleit R, Meurer WJ, Martin R, Rockswold GL. Hyperbaric oxygen brain injury treatment (HOBIT) trial: a multifactor design with response adaptive randomization and longitudinal modeling. Pharm Stat. 2016 Sep;15(5):396-404. doi: 10.1002/pst.1755. Epub 2016 Jun 15.

    PubMed 27306921

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyperbaric oxygen (1.5 ATA, no NBH), Hyperbaric oxygen (2.0 ATA, no NBH) and Hyperbaric oxygen (2.5 ATA, no NBH) in people with Traumatic Brain Injury, run by Gaylan Rockswold at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gaylan L. Rockswold, M.D., Ph.D. (612-873-2810, gaylan.rockswold@hcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glasgow Outcome Scale Extended (GOS-E) (time frame: Assessment at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02407028, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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