Hyperbaric Oxygen Brain Injury Treatment Trial
- Conditions
- Traumatic Brain Injury
- Interventions
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 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 care Usual Care Usual 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
Name Time Method Glasgow Outcome Scale Extended (GOS-E) Assessment at 6 months
- Secondary Outcome Measures
Name Time Method Brain tissue partial pressure of oxygen First 5 days This outcome will be measured only in patients with LICOX monitoring
Serious adverse events 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
Duration of ICP elevation 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) 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 treatments 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).
Trial Locations
- Locations (11)
University of Maryland
๐บ๐ธBaltimore, Maryland, United States
Hamilton Heath Services
๐จ๐ฆHamilton, Ontario, Canada
UCSD Medical Center - Hillcrest Hospital
๐บ๐ธSan Diego, California, United States
Detroit Receiving Hospital
๐บ๐ธDetroit, Michigan, United States
Duke University Hospital
๐บ๐ธDurham, North Carolina, United States
Hennepin County Hospital
๐บ๐ธMinneapolis, Minnesota, United States
University of Iowa Hospitals and Clinics
๐บ๐ธIowa City, Iowa, United States
University of Nebraska Medical Center
๐บ๐ธOmaha, Nebraska, United States
University of Kentucky Hospital
๐บ๐ธLexington, Kentucky, United States
The Ohio State University Wexner Medical Center
๐บ๐ธColumbus, Ohio, United States
St. Mary's Medical Center
๐บ๐ธWest Palm Beach, Florida, United States