Hyperbaric Oxygen Brain Injury Treatment Trial

Last updated: February 6, 2024
Sponsor: Hennepin Healthcare Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Traumatic Brain Injury

Neurologic Disorders

Memory Loss

Treatment

Normobaric Hyperoxia (NBH)

Usual Care

Hyperbaric oxygen (1.5 ATA, no NBH)

Clinical Study ID

NCT02407028
GLR-NIH-2015
  • Ages 16-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orpatients with an alcohol level >200 mg/dl
  • Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admissionin patients not requiring a craniotomy/craniectomy or any other major surgicalprocedure OR
  • Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admissionin patients requiring a craniotomy/craniectomy or major surgical procedure

Exclusion

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 Design

Total Participants: 200
Treatment Group(s): 8
Primary Treatment: Normobaric Hyperoxia (NBH)
Phase: 2
Study Start date:
June 25, 2018
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Hamilton Heath Services

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • HonorHealth Scottsdale Osborn Medical Center

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California 92103
    United States

    Active - Recruiting

  • St. Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kentucky Hospital

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Detroit Receiving Hospital

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Spectrum Health Hospitals Butterworth Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Hennepin County Hospital

    Minneapolis, Minnesota 55415
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

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