Hyperbaric Oxygen Brain Injury Treatment Trial

Part of paid clinical trials in San Diego, California.

Sponsor
Gaylan Rockswold
Study ID
NCT02407028
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperbaric oxygen (1.5 ATA, no NBH) — DRUG
    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) — DRUG
    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) — DRUG
    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) — DRUG
    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) — DRUG
    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) — DRUG
    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) — DRUG
    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 — OTHER
    Will be treated with usual and customary care for severe traumatic brain injury

Study Details

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 Dates

Start date
Jun 25, 2018
Status verified
Aug 2025
Primary completion
Oct 26, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Hyperbaric oxygen (1.5 ATA, no NBH)
    Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
  • Experimental: Hyperbaric oxygen (2.0 ATA, no NBH)
    Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
  • Experimental: Hyperbaric oxygen (2.5 ATA, no NBH)
    Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.
  • Experimental: Hyperbaric oxygen (1.5 ATA + NBH)
    Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
  • Experimental: Hyperbaric oxygen (2.0 ATA + NBH)
    Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
  • Experimental: Hyperbaric oxygen (2.5 ATA + NBH)
    Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
  • Experimental: Normobaric Hyperoxia (NBH)
    Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
  • Active Comparator: Usual care
    Usual care for severe TBI

Primary Outcome Measure

Glasgow Outcome Scale Extended (GOS-E) [ Time Frame: Assessment at 6 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
UCSD Medical Center - Hillcrest HospitalSan DiegoCalifornia92103
Lilian Von Husen
[email protected]
Jessica Weaver, MD (PRINCIPAL_INVESTIGATOR)
St. Mary's Medical CenterWest Palm BeachFlorida33407
Tracy RODRIGUEZ
[email protected]
Faris Azar, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Catherine Fairfield
[email protected]
Nicholas Mohr, MD (PRINCIPAL_INVESTIGATOR)
University of Kentucky HospitalLexingtonKentucky40536
Ronda A PETREY
[email protected]
David Dornbos, MD (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Kinjal Sethuraman, MD (PRINCIPAL_INVESTIGATOR)
Detroit Receiving HospitalDetroitMichigan48201
Anthony Lagina, MD (PRINCIPAL_INVESTIGATOR)
Hennepin County HospitalMinneapolisMinnesota55415
Jessica Gieseke
[email protected]
Sam Cramer, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198-
Duke University HospitalDurhamNorth Carolina27710
Tammy Hawley
[email protected]
Katherine Colton, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical CenterColumbusOhio43210-

Find similar trials in San Diego, CA

By research site
UCSD Medical Center - Hillcrest Hospital· San Diego, CASt. Mary's Medical Center· West Palm Beach, FLUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniversity of Kentucky Hospital· Lexington, KYUniversity of Maryland· Baltimore, MDDetroit Receiving Hospital· Detroit, MI

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