Hyperbaric Oxygen Brain Injury Treatment Trial
HOBIT
1 other identifier
interventional
200
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedStudy Start
First participant enrolled
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
October 3, 2025
August 1, 2025
10.3 years
March 18, 2015
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Glasgow Outcome Scale Extended (GOS-E)
Assessment at 6 months
Secondary Outcomes (5)
Duration of ICP elevation
First 5 days
Therapeutic intensity level scores for controlling intracranial pressure (ICP)
First 5 days
Brain tissue partial pressure of oxygen
First 5 days
Serious adverse events
180 days
Peak brain tissue oxygen (P02) during HBO treatments
First 5 days
Study Arms (8)
Hyperbaric oxygen (1.5 ATA, no NBH)
EXPERIMENTALHyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen (2.0 ATA, no NBH)
EXPERIMENTALHyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen (2.5 ATA, no NBH)
EXPERIMENTALHyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.
Hyperbaric oxygen (1.5 ATA + NBH)
EXPERIMENTALHyperbaric 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 (2.0 ATA + NBH)
EXPERIMENTALHyperbaric 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 (2.5 ATA + NBH)
EXPERIMENTALHyperbaric 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)
EXPERIMENTALNormobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
Usual care
ACTIVE COMPARATORUsual care for severe TBI
Interventions
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
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
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
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
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
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
100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead
Will be treated with usual and customary care for severe traumatic brain injury
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Hennepin County Hospital
Minneapolis, Minnesota, 55415, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Hamilton Heath Services
Hamilton, Ontario, L8L 2X2, Canada
Related Publications (4)
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.
PMID: 31070807BACKGROUNDGajewski 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.
PMID: 27306921BACKGROUNDRockswold 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.
PMID: 19852540BACKGROUNDRockswold 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.
PMID: 23510092BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., Neurosurgery
Study Record Dates
First Submitted
March 18, 2015
First Posted
April 2, 2015
Study Start
June 25, 2018
Primary Completion (Estimated)
October 26, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
October 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share