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Hyperbaric Oxygen Therapy for Traumatic Brain Injury (HOBIT Trial)
HOBIT Trial Summary
This trial is testing different combinations of hyperbaric oxygen treatment to see which is most effective for severe TBI patients.
HOBIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHOBIT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HOBIT Trial Design
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Who is running the clinical trial?
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- I can start hyperbaric oxygen treatment within 8 hours of admission and don't need major surgery.I am between 16 and 65 years old.I have undergone CPR.My coma is thought to be caused by something other than a brain injury.I have no health conditions that prevent me from participating in the study.My severe brain injury score is between 3 to 8.I can start hyperbaric oxygen treatment soon after admission, regardless of needing major surgery.My first hyperbaric oxygen treatment was not within 24 hours of my injury.I have a brain condition like a stroke or TBI that affects my movement or thinking.I can start hyperbaric oxygen therapy within 14 hours after my brain surgery.My CT score is over 1, and I have a severe head injury or high alcohol level.I have a recent, unstable injury to my spinal cord.I have severe difficulty breathing.My blood clotting disorder is stable.My severe brain injury score is between 3 to 8.
- Group 1: Hyperbaric oxygen (1.5 ATA, no NBH)
- Group 2: Hyperbaric oxygen (2.0 ATA, no NBH)
- Group 3: Hyperbaric oxygen (2.0 ATA + NBH)
- Group 4: Usual care
- Group 5: Hyperbaric oxygen (1.5 ATA + NBH)
- Group 6: Normobaric Hyperoxia (NBH)
- Group 7: Hyperbaric oxygen (2.5 ATA, no NBH)
- Group 8: Hyperbaric oxygen (2.5 ATA + NBH)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the current sites for this experiment?
"This research project is being conducted at the University of Maryland in Baltimore, MD and UCSD Medical Center - Hillcrest Hospital in San Diego, CA as well as 11 other sites across the US. Notably, Detroit Receiving Hospital in Detroit, MI is also partaking in this study."
Is the participant pool for this trial comprised of individuals over 40?
"Prospective participants must be aged 16 or above and below the age of 65 to qualify for this trial."
What is the aggregate number of individuals participating in this medical trial?
"The medical trial requires 200 eligible participants. Subjects can access the study from University of Maryland in Baltimore, as well as UCSD Medical Center - Hillcrest Hospital in San Diego."
What risks, if any, are associated with Normobaric Hyperoxia (NBH) treatment?
"The safety of Normobaric Hyperoxia is estimated to be a two, as this is still in the Phase 2 trial stage. There are some studies showing its efficacy but no data yet on how safe it truly can be."
Are there currently any openings in this trial for individuals seeking treatment?
"Absolutely, clinicaltrials.gov lists this trial as presently recruiting patients that meet certain criteria. This study was initially published on June 25th 2018 and the most recent update took place on August 24th 2021. As of now, 11 medical centres are looking to enrol a total of 200 participants."
Would I be eligible to join this trial?
"This study is recruiting 200 individuals between the ages of 16 and 65 who have experienced a traumatic brain injury. Furthermore, applicants must meet additional criteria such as displaying evidence of severe TBI (as measured by Glasgow Coma Scale) and initiating hyperbaric oxygen treatment within 8 to 14 hours depending on whether or not they require major surgery."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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