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RECRUITING
NCT02407028
PHASE2

Hyperbaric Oxygen Brain Injury Treatment Trial

Sponsor: Gaylan Rockswold

View on ClinicalTrials.gov

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.

Official title: Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial

Key Details

Gender

All

Age Range

16 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2018-06-25

Completion Date

2029-06-30

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

OTHER

Usual Care

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

Locations (11)

UCSD Medical Center - Hillcrest Hospital

San Diego, California, United States

St. Mary's Medical Center

West Palm Beach, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kentucky Hospital

Lexington, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Detroit Receiving Hospital

Detroit, Michigan, United States

Hennepin County Hospital

Minneapolis, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Duke University Hospital

Durham, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Hamilton Heath Services

Hamilton, Ontario, Canada