Hyperbaric Oxygen Brain Injury Treatment Trial
Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
Gaylan Rockswold
200 participants
Jun 25, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria11
- 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
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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
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02407028