Hyperbaric Oxygen Brain Injury Treatment Trial

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gaylan Rockswold; Hennepin Healthcare Research Institute
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network

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