Hyperbaric Oxygen Brain Injury Treatment Trial

NCT02407028 · tracked via the Priya Life Science Canada tracker

Sponsor

Gaylan Rockswold

Phase

Phase 2

Started

2018-06-25

Last updated

2026-06-02

Condition(s) studied

Traumatic Brain Injury

Investigational drug(s) / intervention(s)

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)Hyperbaric oxygen (2.5 ATA + NBH)Normobaric Hyperoxia (NBH)Usual Care

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

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

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

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

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

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

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

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

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

Sex

ALL

Min age

16 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Glasgow Outcome Scale Extended (GOS-E) — Assessment at 6 months

Trial sites (11)

Facility	City	Region	Status
UCSD Medical Center - Hillcrest Hospital	San Diego	California	Recruiting
St. Mary's Medical Center	West Palm Beach	Florida	Recruiting
University of Iowa Hospitals and Clinics	Iowa City	Iowa	Recruiting
University of Kentucky Hospital	Lexington	Kentucky	Recruiting
University of Maryland	Baltimore	Maryland	Recruiting
Detroit Receiving Hospital	Detroit	Michigan	Recruiting
Hennepin County Hospital	Minneapolis	Minnesota	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	Completed
Duke University Hospital	Durham	North Carolina	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	Completed
Hamilton Heath Services	Hamilton	Ontario	Completed

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02407028 on ClinicalTrials.gov ↗ ← All trials in Canada