Phase
Condition
Neurologic Disorders
Traumatic Brain Injury
Memory Loss
Treatment
Hyperbaric oxygen (2.0 ATA, no NBH)
Hyperbaric oxygen (2.5 ATA + NBH)
Normobaric Hyperoxia (NBH)
Clinical Study ID
Ages 16-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orpatients with an alcohol level >200 mg/dl
Ability to initiate the first hyperbaric oxygen treatment within 8 hours ofadmission in patients not requiring a craniotomy/craniectomy or any other majorsurgical procedure OR
Ability to initiate the first hyperbaric oxygen treatment within 14 hours ofadmission in patients requiring a craniotomy/craniectomy or major surgical procedure
Exclusion
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
Study Design
Study Description
Connect with a study center
Hamilton Heath Services
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
Hamilton Heath Services
Hamilton 5969782, Ontario 6093943 L8L 2X2
CanadaSite Not Available
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona 85251
United StatesSite Not Available
UCSD Medical Center - Hillcrest Hospital
San Diego, California 92103
United StatesSite Not Available
UCSD Medical Center - Hillcrest Hospital
San Diego 5391811, California 5332921 92103
United StatesActive - Recruiting
St. Mary's Medical Center
West Palm Beach, Florida 33407
United StatesSite Not Available
St. Mary's Medical Center
West Palm Beach 4177887, Florida 4155751 33407
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
University of Kentucky Hospital
Lexington, Kentucky 40536
United StatesSite Not Available
University of Kentucky Hospital
Lexington 4297983, Kentucky 6254925 40536
United StatesActive - Recruiting
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
University of Maryland
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
Detroit Receiving Hospital
Detroit, Michigan 48201
United StatesSite Not Available
Spectrum Health Hospitals Butterworth Hospital
Grand Rapids, Michigan 49503
United StatesSite Not Available
Detroit Receiving Hospital
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Hennepin County Hospital
Minneapolis, Minnesota 55415
United StatesSite Not Available
Hennepin County Hospital
Minneapolis 5037649, Minnesota 5037779 55415
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesActive - Recruiting
Duke University Hospital
Durham, North Carolina 27710
United StatesSite Not Available
Duke University Hospital
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Baylor University Medical Center
Dallas, Texas 75246
United StatesSite Not Available

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