Actively Recruiting
Hyperbaric Oxygen Brain Injury Treatment Trial
Led by Gaylan Rockswold · Updated on 2025-10-03
200
Participants Needed
11
Research Sites
574 weeks
Total Duration
On this page
Sponsors
G
Gaylan Rockswold
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hyperbaric Oxygen Brain Injury Treatment Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older and 65 years or younger
- Severe traumatic brain injury with Glasgow Coma Scale (GCS) score of 3 to 8
- Marshall CT score greater than 1 for patients with GCS of 7 or 8 or with alcohol level over 200 mg/dl
- Ability to start first hyperbaric oxygen treatment within 8 hours of admission if no major surgery needed
- Ability to start first hyperbaric oxygen treatment within 14 hours of admission if major surgery required
You will not qualify if you...
- Cannot start first hyperbaric oxygen treatment within 24 hours of injury
- GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)
- Penetrating head injury
- Pregnant
- Pre-existing neurological disease causing residual deficits (such as prior TBI, stroke, or neurodegenerative disorder)
- Unstable acute spinal cord injury
- Fixed coagulopathy
- Severe hypoxia
- Cardiopulmonary resuscitation performed
- Coma suspected from mainly non-TBI causes
- Any contraindications to the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States, 92103
Actively Recruiting
2
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
University of Kentucky Hospital
Lexington, Kentucky, United States, 40536
Actively Recruiting
5
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
6
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Actively Recruiting
7
Hennepin County Hospital
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
8
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
9
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
10
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Active, Not Recruiting
11
Hamilton Heath Services
Hamilton, Ontario, Canada, L8L 2X2
Active, Not Recruiting
Research Team
G
Gaylan L. Rockswold, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here