RecruitingPhase 2NCT02407028

Hyperbaric Oxygen Brain Injury Treatment Trial

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial


Sponsor

Gaylan Rockswold

Enrollment

200 participants

Start Date

Jun 25, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hyperbaric oxygen (1.5 ATA + NBH), a drug called Hyperbaric oxygen (1.5 ATA, no NBH), and others for people with traumatic brain injury. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 16 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHyperbaric 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

DRUGHyperbaric 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

DRUGHyperbaric 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

DRUGHyperbaric 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

DRUGHyperbaric 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

DRUGHyperbaric 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

DRUGNormobaric 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

OTHERUsual 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

View Full Details on ClinicalTrials.gov

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NCT02407028


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