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Hyperbaric Oxygen Brain Injury Treatment Trial
Sponsor: Gaylan Rockswold
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
Conditions
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
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