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NCT Number: NCT02407028

Hyperbaric Oxygen Brain Injury Treatment 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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamilton Heath Services, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric oxygen (1.5 ATA, no NBH)

Drug

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

Hyperbaric oxygen (2.0 ATA, no NBH)

Drug

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

Hyperbaric oxygen (2.5 ATA, no NBH)

Drug

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

Hyperbaric oxygen (1.5 ATA + NBH)

Drug

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

Hyperbaric oxygen (2.0 ATA + NBH)

Drug

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

Hyperbaric oxygen (2.5 ATA + NBH)

Drug

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

Normobaric Hyperoxia (NBH)

Drug

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

Usual Care

Other

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

Other names: Standard of Care

Primary outcomes

  1. Glasgow Outcome Scale Extended (GOS-E)

    Time frame: Assessment at 6 months

Secondary outcomes

  1. Duration of ICP elevation

    Time frame: First 5 days

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

  2. 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

  3. Brain tissue partial pressure of oxygen

    Time frame: First 5 days

    This outcome will be measured only in patients with LICOX monitoring

  4. 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

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

612-873-2810

Sponsors and collaborators

Lead sponsor

Gaylan Rockswold

Other

Collaborators

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

Registry information

Official study title

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial

Acronym: HOBIT

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Apr 2, 2015
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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