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HOBIT (Traumatic Brain Injury) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if hyperbaric oxygen therapy is helpful to people with traumatic brain injury.

What is the Condition Being Studied?

Traumatic Brain Injury (TBI)

Who Can Participate in the Study?

Children and adults ages 16-65 who:

  • Have a traumatic brain injury
  • Able to complete their first hyperbaric treatment within 8-14 hours of being admitted to the hospital
    • Age Group
    Adults, Children

    What is Involved?

    If you choose to join this, study you will get a random assignment (like drawing numbers out of a hat) to be 1 one of 8 groups:

  • 6 groups will receive hyperbaric oxygen therapy
  • 1 group will receive a high dose of oxygen that is not pressurized
  • 1 group will get standard care

    • All study participants will complete a follow-up visit (on the phone or in-person) at months 3 and 6 after treatment.

    Study Details

    Full Title
    Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial: A Multicenter, Randomized, Prospective Phase II Adaptive Clinical Trial Evaluating the Most Effective Hyperbaric Oxygen Treatment Paradigm for Severe Traumatic Brain Injury
    Principal Investigator
    Protocol Number
    IRB: PRO00093798
    NCT: NCT02407028
    Phase
    Phase II
    ClinicalTrials.gov
    Enrollment Status
    Open for Enrollment
    Participate
    Contact the Duke Recruitment Innovation Center
    MyResearchPartners@duke.edu
    or
    919-681-5698

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