Hyperbaric Oxygen Brain Injury Treatment Trial
Trial Parameters
Brief 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 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