Hyperbaric Oxygen Brain Injury Treatment Trial
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.
- Traumatic Brain Injury
- Eligible Ages
- Between 16 Years and 65 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- 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
- Phase 2
- Study Type
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Single (Outcomes Assessor)
|Patients in this arm will be assigned to one of three different pressures of hyperbaric oxygen with or without normobaric hyperoxia||
|Patients will be assigned to normobaric hyperoxia only||
|Patients will be assigned to usual care||
- Hennepin Healthcare Research Institute.
Study ContactGaylan L. Rockswold, M.D., Ph.D.
Preclinical and clinical investigations strongly indicate that hyperbaric oxygen (HBO2) is physiologically active in improving the destructive processes in severe Traumatic Brain Injury (TBI). However, prior to a definitive efficacy study, important information is required regarding optimizing the HBO2 treatment paradigm instituted in terms of pressure and whether NBH enhances the clinical effectiveness of the HBO2 treatment. Preclinical investigators working with TBI models have used pressures varying from 1.5 to 3.0 atmospheres absolute (ATA). Clinical investigators have used pressure varying from 1.5 to 2.5 ATA. However, the lungs in severe TBI patients have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to oxygen (O2) toxicity. Working within these constraints, it is essential to determine the most effective HBO2 treatment parameters without producing O2 toxicity and clinical complications. This proposed clinical trial is designed to answer these questions and to provide important data to plan a definitive efficacy trial.