At a glance
ClinicalIndex Comparison Record- ✓Age 16-65 years
- ✓Severe TBI with GCS 3-8
- ✓Marshall CT score >1 for GCS 7-8 or alcohol level >200 mg/dl
- ✓Can initiate hyperbaric oxygen within 8 hours (no craniotomy/craniectomy) or 14 hours (with craniotomy/craniectomy)
- ✕Cannot initiate hyperbaric oxygen within 24 hours of injury
- ✕GCS 3 with mid-position, non-reactive pupils bilaterally (4mm)
- ✕Penetrating head injury
- ✕Pregnant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
In Brief
A Phase 2 clinical trial evaluating Hyperbaric oxygen (1.5 ATA, no NBH), Hyperbaric oxygen (2.0 ATA, no NBH), and 6 other interventions for Traumatic Brain Injury. Currently recruiting, targeting 200 participants across 11 sites in 2 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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
Interventions
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
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
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
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
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
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
100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead
Will be treated with usual and customary care for severe traumatic brain injury