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Hyperbaric Oxygen Brain Injury Treatment Trial (HOBIT)

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ClinicalTrials.gov Identifier: NCT02407028
Recruitment Status : Recruiting
First Posted : April 2, 2015
Last Update Posted : August 27, 2021
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Tracking Information
First Submitted Date  ICMJE March 18, 2015
First Posted Date  ICMJE April 2, 2015
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE June 25, 2018
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
Glasgow Outcome Scale Extended (GOS-E) [ Time Frame: Assessment at 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • Glasgow Outcome Score (GOS) [ Time Frame: Assessment at 3 months ]
  • Glasgow Outcome Score (GOS) [ Time Frame: Assessment at 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
  • Duration of ICP elevation [ Time Frame: First 5 days ]
    The duration of ICP elevation will be measured using the area under the curve methodology
  • Therapeutic intensity level scores for controlling intracranial pressure (ICP) [ Time Frame: First 5 days ]
    This tracks the level of therapies used to control ICP during the first 5 days
  • Brain tissue partial pressure of oxygen [ Time Frame: First 5 days ]
    This outcome will be measured only in patients with LICOX monitoring
  • Serious adverse events [ Time Frame: 180 days ]
    Events resulting in death, a life-threatening adverse event, or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • Peak brain tissue oxygen (P02) during HBO treatments [ Time Frame: First 5 days ]
    To examine the association between peak brain tissue PO2 during hyperbaric treatment and favorable outcome at 6-months (measured by the GOS-E).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • Secondary Outcomes- Disability rating scale [ Time Frame: Assessment at 3 months ]
    Disability rating scale (DRS, 28 day survival, ventilator, ICU and hospital free days, incidence of severe adverse events
  • Secondary Outcomes- Disability rating scale [ Time Frame: Assessment at 6 months ]
    Disability rating scale (DRS, 28 day survival, ventilator, ICU and hospital free
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen Brain Injury Treatment Trial
Official Title  ICMJE Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
Brief Summary 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.
Detailed Description Preclinical and clinical investigations strongly indicate that hyperbaric oxygen (HBO2) is physiologically active in improving the destructive processes in severe Traumatic Brain Injury (TBI). However, prior to a definitive efficacy study, important information is required regarding optimizing the HBO2 treatment paradigm instituted in terms of pressure and whether NBH enhances the clinical effectiveness of the HBO2 treatment. Preclinical investigators working with TBI models have used pressures varying from 1.5 to 3.0 atmospheres absolute (ATA). Clinical investigators have used pressure varying from 1.5 to 2.5 ATA. However, the lungs in severe TBI patients have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to oxygen (O2) toxicity. Working within these constraints, it is essential to determine the most effective HBO2 treatment parameters without producing O2 toxicity and clinical complications. This proposed clinical trial is designed to answer these questions and to provide important data to plan a definitive efficacy trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Drug: 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
    Other Name: HBO
  • Drug: 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
    Other Name: HBO
  • Drug: 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
    Other Name: HBO
  • Drug: 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
    Other Name: HBO
  • Drug: 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
    Other Name: HBO
  • Drug: 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
    Other Name: HBO
  • Drug: 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
    Other Name: NBH
  • Other: Usual Care
    Will be treated with usual and customary care for severe traumatic brain injury
    Other Name: Standard of Care
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Hyperbaric oxygen (1.5 ATA, no NBH)
  • 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.
    Intervention: Drug: Hyperbaric oxygen (2.0 ATA, no NBH)
  • 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.
    Intervention: Drug: Hyperbaric oxygen (2.5 ATA, no NBH)
  • 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.
    Intervention: Drug: Hyperbaric oxygen (1.5 ATA + NBH)
  • 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.
    Intervention: Drug: Hyperbaric oxygen (2.0 ATA + NBH)
  • 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.
    Intervention: Drug: Hyperbaric oxygen (2.5 ATA + NBH)
  • Experimental: Normobaric Hyperoxia (NBH)
    Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
    Intervention: Drug: Normobaric Hyperoxia (NBH)
  • Active Comparator: Usual care
    Usual care for severe TBI
    Intervention: Other: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gaylan L. Rockswold, M.D., Ph.D. 612-873-2810 gaylan.rockswold@hcmed.org
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02407028
Other Study ID Numbers  ICMJE GLR-NIH-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hennepin Healthcare Research Institute
Study Sponsor  ICMJE Hennepin Healthcare Research Institute
Collaborators  ICMJE
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
Investigators  ICMJE
Principal Investigator: Gaylan L Rockswold, M.D., Ph.D. Hennepin County Medical Center, Minneapolis
Principal Investigator: William Barsan, MD University of Michigan
Principal Investigator: Byron Gajewski, Ph.D. University of Kansas Medical Center
Principal Investigator: Frederick K Korley, M.D., Ph.D. University of Michigan
PRS Account Hennepin Healthcare Research Institute
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP