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Hyperbaric Oxygen Brain Injury Treatment Trial

Registration Number
NCT02407028
Lead Sponsor
Hennepin Healthcare Research Institute
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Hyperbaric oxygen (1.5 ATA, no NBH)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.
Hyperbaric oxygen (2.0 ATA, no NBH)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.
Hyperbaric oxygen (2.5 ATA, no NBH)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.
Hyperbaric oxygen (2.0 ATA + NBH)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.
Normobaric Hyperoxia (NBH)Normobaric Hyperoxia (NBH)Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
Usual careUsual CareUsual care for severe TBI
Hyperbaric oxygen (1.5 ATA + NBH)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.
Hyperbaric oxygen (2.5 ATA + NBH)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.
Primary Outcome Measures
NameTimeMethod
Glasgow Outcome Scale Extended (GOS-E)Assessment at 6 months
Secondary Outcome Measures
NameTimeMethod
Brain tissue partial pressure of oxygenFirst 5 days

This outcome will be measured only in patients with LICOX monitoring

Serious adverse events180 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

Duration of ICP elevationFirst 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)First 5 days

This tracks the level of therapies used to control ICP during the first 5 days

Peak brain tissue oxygen (P02) during HBO treatmentsFirst 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).

Trial Locations

Locations (11)

University of Maryland

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Baltimore, Maryland, United States

Hamilton Heath Services

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Hamilton, Ontario, Canada

UCSD Medical Center - Hillcrest Hospital

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San Diego, California, United States

Detroit Receiving Hospital

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Detroit, Michigan, United States

Duke University Hospital

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Durham, North Carolina, United States

Hennepin County Hospital

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Minneapolis, Minnesota, United States

University of Iowa Hospitals and Clinics

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Iowa City, Iowa, United States

University of Nebraska Medical Center

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Omaha, Nebraska, United States

University of Kentucky Hospital

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Lexington, Kentucky, United States

The Ohio State University Wexner Medical Center

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Columbus, Ohio, United States

St. Mary's Medical Center

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West Palm Beach, Florida, United States

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