Hyperbaric oxygen treatment for severe brain injury
Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
This study is testing different ways of using hyperbaric oxygen treatment to see if it can help people with severe brain injuries feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Hennepin Healthcare Research Institute Academic / other |
| Locations | 11 sites (San Diego, California and 10 other locations) |
| Trial ID | NCT02407028 on ClinicalTrials.gov |
What this trial studies
This phase II trial aims to identify the optimal parameters for hyperbaric oxygen (HBO2) treatment in patients with severe traumatic brain injury (TBI). The study will evaluate various combinations of pressure levels and the potential enhancement of treatment effectiveness through the use of non-breathing hyperbaric (NBH) techniques. By determining the most effective HBO2 treatment parameters, the trial seeks to provide critical data for a future definitive efficacy trial. The focus is on minimizing oxygen toxicity while maximizing therapeutic benefits for patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 65 who present with severe TBI and meet specific clinical criteria.
Not a fit: Patients with pre-existing neurological diseases or those who cannot receive treatment within the specified time frame may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with severe traumatic brain injury.
How similar studies have performed: Previous studies have indicated potential benefits of hyperbaric oxygen therapy in TBI, but this specific approach is novel and aims to refine treatment parameters.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 16 years or older and 65 years or younger * Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8. * Marshall computerized tomography (CT) score \>1 in patients with a GCS of 7 or 8 or patients with an alcohol level \>200 mg/dl * Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy/craniectomy or any other major surgical procedure OR * Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy/craniectomy or major surgical procedure Exclusion Criteria: * First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury * GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm) * Penetrating head injury * Pregnant * Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits * Unstable acute spinal cord injury * Fixed coagulopathy * Severe hypoxia * Cardiopulmonary resuscitation performed * Coma suspected to de due to primarily non-TBI causes * Any contraindications to the study intervention
Where this trial is running
San Diego, California and 10 other locations
- UCSD Medical Center - Hillcrest Hospital — San Diego, California, United States (Recruiting)
- St. Mary's Medical Center — West Palm Beach, Florida, United States (Recruiting)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
- University of Kentucky Hospital — Lexington, Kentucky, United States (Recruiting)
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
- Detroit Receiving Hospital — Detroit, Michigan, United States (Recruiting)
- Hennepin County Hospital — Minneapolis, Minnesota, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Duke University Hospital — Durham, North Carolina, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Active_not_recruiting)
- Hamilton Heath Services — Hamilton, Ontario, Canada (Active_not_recruiting)
Study contacts
- Principal investigator: Gaylan L Rockswold, M.D., Ph.D. — Hennepin County Medical Center, Minneapolis
- Study coordinator: Gaylan L. Rockswold, M.D., Ph.D.
- Email: gaylan.rockswold@hcmed.org
- Phone: 612-873-2810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.