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Hyperbaric Oxygen Brain Injury Treatment Trial (HOBIT)

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Hyperbaric oxygen (1.5 ATA, no NBH)
Hyperbaric oxygen (2.0 ATA, no NBH)
Hyperbaric oxygen (2.5 ATA, no NBH)
Hyperbaric oxygen (1.5 ATA + NBH)
Hyperbaric oxygen (2.0 ATA + NBH)
Hyperbaric oxygen (2.5 ATA + NBH)
Normobaric Hyperoxia (NBH)
Usual Care
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Medical Center - Hillcrest HospitalRecruiting
  • St. Mary's Medical CenterRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of Kentucky HospitalRecruiting
  • University of MarylandRecruiting
  • Detroit Receiving HospitalRecruiting
  • Hennepin County HospitalRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Duke University HospitalRecruiting
  • The Ohio State University Wexner Medical Center
  • Hamilton Heath Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Hyperbaric oxygen (1.5 ATA, no NBH)

Hyperbaric oxygen (2.0 ATA, no NBH)

Hyperbaric oxygen (2.5 ATA, no NBH)

Hyperbaric oxygen (1.5 ATA + NBH)

Hyperbaric oxygen (2.0 ATA + NBH)

Hyperbaric oxygen (2.5 ATA + NBH)

Normobaric Hyperoxia (NBH)

Usual care

Arm Description

Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.

Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.

Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.

Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.

Usual care for severe TBI

Outcomes

Primary Outcome Measures

Glasgow Outcome Scale Extended (GOS-E)

Secondary Outcome Measures

Duration of ICP elevation
The duration of ICP elevation will be measured using the area under the curve methodology
Therapeutic intensity level scores for controlling intracranial pressure (ICP)
This tracks the level of therapies used to control ICP during the first 5 days
Brain tissue partial pressure of oxygen
This outcome will be measured only in patients with LICOX monitoring
Serious adverse events
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
To examine the association between peak brain tissue PO2 during hyperbaric treatment and favorable outcome at 6-months (measured by the GOS-E).

Full Information

First Posted
March 18, 2015
Last Updated
December 9, 2022
Sponsor
Hennepin Healthcare Research Institute
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
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1. Study Identification

Unique Protocol Identification Number
NCT02407028
Brief Title
Hyperbaric Oxygen Brain Injury Treatment Trial
Acronym
HOBIT
Official Title
Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen (1.5 ATA, no NBH)
Arm Type
Experimental
Arm Description
Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Arm Title
Hyperbaric oxygen (2.0 ATA, no NBH)
Arm Type
Experimental
Arm Description
Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Arm Title
Hyperbaric oxygen (2.5 ATA, no NBH)
Arm Type
Experimental
Arm Description
Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.
Arm Title
Hyperbaric oxygen (1.5 ATA + NBH)
Arm Type
Experimental
Arm Description
Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Arm Title
Hyperbaric oxygen (2.0 ATA + NBH)
Arm Type
Experimental
Arm Description
Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Arm Title
Hyperbaric oxygen (2.5 ATA + NBH)
Arm Type
Experimental
Arm Description
Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
Arm Title
Normobaric Hyperoxia (NBH)
Arm Type
Experimental
Arm Description
Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care for severe TBI
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen (1.5 ATA, no NBH)
Other Intervention Name(s)
HBO
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen (2.0 ATA, no NBH)
Other Intervention Name(s)
HBO
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen (2.5 ATA, no NBH)
Other Intervention Name(s)
HBO
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen (1.5 ATA + NBH)
Other Intervention Name(s)
HBO
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen (2.0 ATA + NBH)
Other Intervention Name(s)
HBO
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen (2.5 ATA + NBH)
Other Intervention Name(s)
HBO
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normobaric Hyperoxia (NBH)
Other Intervention Name(s)
NBH
Intervention Description
100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Standard of Care
Intervention Description
Will be treated with usual and customary care for severe traumatic brain injury
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale Extended (GOS-E)
Time Frame
Assessment at 6 months
Secondary Outcome Measure Information:
Title
Duration of ICP elevation
Description
The duration of ICP elevation will be measured using the area under the curve methodology
Time Frame
First 5 days
Title
Therapeutic intensity level scores for controlling intracranial pressure (ICP)
Description
This tracks the level of therapies used to control ICP during the first 5 days
Time Frame
First 5 days
Title
Brain tissue partial pressure of oxygen
Description
This outcome will be measured only in patients with LICOX monitoring
Time Frame
First 5 days
Title
Serious adverse events
Description
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
Time Frame
180 days
Title
Peak brain tissue oxygen (P02) during HBO treatments
Description
To examine the association between peak brain tissue PO2 during hyperbaric treatment and favorable outcome at 6-months (measured by the GOS-E).
Time Frame
First 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaylan L. Rockswold, M.D., Ph.D.
Phone
612-873-2810
Email
gaylan.rockswold@hcmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaylan L Rockswold, M.D., Ph.D.
Organizational Affiliation
Hennepin County Medical Center, Minneapolis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Barsan, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byron Gajewski, Ph.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederick K Korley, M.D., Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center - Hillcrest Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Curry
Email
tcurry@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Todd Constantini, MD
Facility Name
St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy RODRIGUEZ
Email
Tracy.Rodriguez@tenethealth.com
First Name & Middle Initial & Last Name & Degree
Robert Borrego, MD
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Fairfield
Email
catherine-fairfield@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Nicholas Mohr, MD
Facility Name
University of Kentucky Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronda A Ronda PETREY
Email
ronda.petrey@uky.edu
First Name & Middle Initial & Last Name & Degree
Kevin Hatton, MD
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Sult
Email
lsult@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Kinjal Sethuraman, MD
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farhan Ayaz
Email
sfayaz@med.wayne.edu
First Name & Middle Initial & Last Name & Degree
Anthony Lagina, MD
Facility Name
Hennepin County Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe LAWYER
Email
lawye010@umn.edu
First Name & Middle Initial & Last Name & Degree
Tom Bergman, MD, PhD
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooklin K Zimmerman
Email
brooklin.zimmerman@unmc.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Cooper, MD
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmalee Metzler
Email
emmalee.metzler@duke.edu
First Name & Middle Initial & Last Name & Degree
Michael James, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hamilton Heath Services
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
31070807
Citation
Gajewski BJ, Meinzer C, Berry SM, Rockswold GL, Barsan WG, Korley FK, Martin RH. Bayesian hierarchical EMAX model for dose-response in early phase efficacy clinical trials. Stat Med. 2019 Jul 30;38(17):3123-3138. doi: 10.1002/sim.8167. Epub 2019 May 9.
Results Reference
background
PubMed Identifier
27306921
Citation
Gajewski BJ, Berry SM, Barsan WG, Silbergleit R, Meurer WJ, Martin R, Rockswold GL. Hyperbaric oxygen brain injury treatment (HOBIT) trial: a multifactor design with response adaptive randomization and longitudinal modeling. Pharm Stat. 2016 Sep;15(5):396-404. doi: 10.1002/pst.1755. Epub 2016 Jun 15.
Results Reference
background
PubMed Identifier
19852540
Citation
Rockswold SB, Rockswold GL, Zaun DA, Zhang X, Cerra CE, Bergman TA, Liu J. A prospective, randomized clinical trial to compare the effect of hyperbaric to normobaric hyperoxia on cerebral metabolism, intracranial pressure, and oxygen toxicity in severe traumatic brain injury. J Neurosurg. 2010 May;112(5):1080-94. doi: 10.3171/2009.7.JNS09363.
Results Reference
background
PubMed Identifier
23510092
Citation
Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.
Results Reference
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Hyperbaric Oxygen Brain Injury Treatment Trial

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