Hyperbaric Oxygen Brain Injury Treatment Trial

Recruiting now · Phase 2

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT02407028

Run by

Gaylan Rockswold

People needed

200

Starts

2018-06-25

Expected to finish

2029-06-30

Last updated by the study team

2026-06-02

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSD Medical Center - Hillcrest Hospital — San Diego, California, United States (enrolling)
• St. Mary's Medical Center — West Palm Beach, Florida, United States (enrolling)
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
• University of Kentucky Hospital — Lexington, Kentucky, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Detroit Receiving Hospital — Detroit, Michigan, United States (enrolling)
• Hennepin County Hospital — Minneapolis, Minnesota, United States (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• Hamilton Heath Services — Hamilton, Ontario, Canada
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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