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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 : December 18, 2018
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):
Minneapolis Medical Research Foundation

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Hyperbaric oxygen (1.5 ATA, no NBH) Drug: Hyperbaric oxygen (2.0 ATA, no NBH) Drug: Hyperbaric oxygen (2.5 ATA, no NBH) Drug: Hyperbaric oxygen (1.5 ATA + NBH) Drug: Hyperbaric oxygen (2.0 ATA + NBH) Drug: Hyperbaric oxygen (2.5 ATA + NBH) Drug: Normobaric Hyperoxia (NBH) Other: Usual Care Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Hyperbaric Oxygen
Patients in this arm will be assigned to one of three different pressures of hyperbaric oxygen with or without normobaric hyperoxia
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

Active Comparator: NBH
Patients will be assigned to normobaric hyperoxia only
Drug: Normobaric Hyperoxia (NBH)
100% FiO2 for 4.5 hours twice a day for five days or until patient following commands or brain dead
Other Name: NBH

Placebo Comparator: Placebo
Patients will be assigned to usual care
Other: Usual Care
Will be treated with usual and customary care for severe traumatic brain injury
Other Name: Standard of Care




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

Secondary Outcome Measures :
  1. Duration of ICP elevation [ Time Frame: First 5 days ]
    The duration of ICP elevation will be measured using the area under the curve methodology

  2. Therapeutic intensity level scores for controlling ICP [ Time Frame: First 5 days ]
    This tracks the level of therapies used to control ICP during the first 5 days

  3. Brain tissue partial pressure of oxygen [ Time Frame: First 5 days ]
    This outcome will be measured only in patients with LICOX monitoring

  4. 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



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 16 years or older and 65 years or younger
  • Present with severe TBI, defined as 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407028


Contacts
Contact: Gaylan L. Rockswold, MD 612-873-2810 gaylan.rockswold@hcmed.org

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Catherine Fairfield         
United States, Kentucky
University of Kentucky Hospital Recruiting
Lexington, Kentucky, United States, 40536
Contact: Joann Short         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Leslie Sult         
United States, Minnesota
Hennepin County Hospital Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Abbey Staugaitis         
Principal Investigator: Tom Bergman, MD, PhD         
United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Erlinda Yeh         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Karina Woodling         
Sponsors and Collaborators
Minneapolis Medical Research Foundation
National Institute of Neurological Disorders and Stroke (NINDS)
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
Investigators
Principal Investigator: Gaylan L Rockswold, MD Hennepin County Medical Center, Minneapolis
Principal Investigator: William Barsan, MD University of Michigan
Principal Investigator: Byron Gajewski, Ph.D. University of Kansas Medical Center

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02407028     History of Changes
Other Study ID Numbers: GLR-NIH-2015
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System