Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial

ID
Name
GLR-NIH-2015
Description
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.
Trial arms
Trial start
2018-06-25
Estimated PCD
2026-10-01
Trial end
2027-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Hyperbaric oxygen (1.5 ATA, no NBH)
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
Arms:
Hyperbaric oxygen (1.5 ATA, no NBH)
Other names:
HBO
Hyperbaric oxygen (2.0 ATA, no NBH)
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
Arms:
Hyperbaric oxygen (2.0 ATA, no NBH)
Other names:
HBO
Hyperbaric oxygen (2.5 ATA, no NBH)
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
Arms:
Hyperbaric oxygen (2.5 ATA, no NBH)
Other names:
HBO
Hyperbaric oxygen (1.5 ATA + NBH)
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
Arms:
Hyperbaric oxygen (1.5 ATA + NBH)
Other names:
HBO
Hyperbaric oxygen (2.0 ATA + NBH)
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
Arms:
Hyperbaric oxygen (2.0 ATA + NBH)
Other names:
HBO
Hyperbaric oxygen (2.5 ATA + NBH)
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
Arms:
Hyperbaric oxygen (2.5 ATA + NBH)
Other names:
HBO
Normobaric Hyperoxia (NBH)
100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead
Arms:
Normobaric Hyperoxia (NBH)
Other names:
NBH
Usual Care
Will be treated with usual and customary care for severe traumatic brain injury
Arms:
Usual care
Other names:
Standard of Care
Size
200
Primary endpoint
Glasgow Outcome Scale Extended (GOS-E)
Assessment at 6 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-02-08

1 organization

2 products

1 indication

Organization
Hennepin Healthcare Research Institute
Product
Hyperbaric oxygen
Indication
Traumatic Brain Injury
Product
Normobaric Hyperoxia