200
Participants
Start Date
June 25, 2018
Primary Completion Date
October 26, 2028
Study Completion Date
June 30, 2029
Hyperbaric oxygen (1.5 ATA, no NBH)
HBO at 1.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
Hyperbaric oxygen (2.0 ATA, no NBH)
HBO at 2.0 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
Hyperbaric oxygen (2.5 ATA, no NBH)
HBO at 2.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
Hyperbaric oxygen (1.5 ATA + NBH)
HBO at 1.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
Hyperbaric oxygen (2.0 ATA + NBH)
HBO at 2.0 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
Hyperbaric oxygen (2.5 ATA + NBH)
HBO at 2.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
Normobaric Hyperoxia (NBH)
100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead
Usual Care
Will be treated with usual and customary care for severe traumatic brain injury
RECRUITING
University of Maryland, Baltimore
RECRUITING
Duke University Hospital, Durham
RECRUITING
St. Mary's Medical Center, West Palm Beach
RECRUITING
University of Kentucky Hospital, Lexington
ACTIVE_NOT_RECRUITING
The Ohio State University Wexner Medical Center, Columbus
RECRUITING
Detroit Receiving Hospital, Detroit
RECRUITING
University of Iowa Hospitals and Clinics, Iowa City
RECRUITING
Hennepin County Hospital, Minneapolis
RECRUITING
University of Nebraska Medical Center, Omaha
RECRUITING
UCSD Medical Center - Hillcrest Hospital, San Diego
ACTIVE_NOT_RECRUITING
Hamilton Heath Services, Hamilton
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Strategies to Innovate EmeRgENcy Care Clinical Trials Network
NETWORK
Gaylan Rockswold
OTHER