Recruiting
Phase 2

Hyperbaric Oxygen

Sponsor:

Gaylan Rockswold

Code:

NCT02407028

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Interventions

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)

Study Details

Brief 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.

Conditions

Traumatic Brain Injury

Study ID

NCT02407028

Start date

Jun 25, 2018

Status verified date

Aug, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Oct 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

experimental: Normobaric Hyperoxia (NBH)

Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.

active comparator: Usual care

Usual care for severe TBI

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

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

612-873-2810gaylan.rockswold@hcmed.org

Locations

UCSD Medical Center - Hillcrest Hospital

Recruiting

San Diego, California, United States, 92103

Contacts

Lilian Von Husen

lvonhuse@health.ucsd.edu

Principal Investigator:

Jessica Weaver, MD

St. Mary's Medical Center

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Tracy RODRIGUEZ

Tracy.Rodriguez@tenethealth.com

Principal Investigator:

Faris Azar, MD

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Catherine Fairfield

catherine-fairfield@uiowa.edu

Principal Investigator:

Nicholas Mohr, MD

University of Kentucky Hospital

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Ronda A PETREY

ronda.petrey@uky.edu

Principal Investigator:

David Dornbos, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Leslie Sult

lsult@som.umaryland.edu

Principal Investigator:

Kinjal Sethuraman, MD

Detroit Receiving Hospital

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Nick Wesner

nicholas.wesner@wayne.edu

Principal Investigator:

Anthony Lagina, MD

Hennepin County Hospital

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Jessica Gieseke

giese141@umn.edu

Principal Investigator:

Sam Cramer, MD, PhD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Tammy Hawley

tammy.hawley@duke.edu

Principal Investigator:

Katherine Colton, MD

More Information

Sponsor

Gaylan Rockswold

Last update posted

Jun 2, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gaylan Rockswold on 2026-06-02.