Hyperbaric Oxygen Brain Injury Treatment Trial (HOBIT)
Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility 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
Sites / Locations
- UCSD Medical Center - Hillcrest HospitalRecruiting
- St. Mary's Medical CenterRecruiting
- University of Iowa Hospitals and ClinicsRecruiting
- University of Kentucky HospitalRecruiting
- University of MarylandRecruiting
- Detroit Receiving HospitalRecruiting
- Hennepin County HospitalRecruiting
- University of Nebraska Medical CenterRecruiting
- Duke University HospitalRecruiting
- The Ohio State University Wexner Medical Center
- Hamilton Heath Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Hyperbaric oxygen (1.5 ATA, no NBH)
Hyperbaric oxygen (2.0 ATA, no NBH)
Hyperbaric oxygen (2.5 ATA, no NBH)
Hyperbaric oxygen (1.5 ATA + NBH)
Hyperbaric oxygen (2.0 ATA + NBH)
Hyperbaric oxygen (2.5 ATA + NBH)
Normobaric Hyperoxia (NBH)
Usual care
Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
Usual care for severe TBI