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Hyperbaric Oxygen Brain Injury Treatment Trial

ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-65
SponsorGaylan Rockswold

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Hyperbaric oxygen (1.5 ATA, no NBH)

    Drug

    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

  • Hyperbaric oxygen (2.0 ATA, no NBH)

    Drug

    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

  • Hyperbaric oxygen (2.5 ATA, no NBH)

    Drug

    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

  • Hyperbaric oxygen (1.5 ATA + NBH)

    Drug

    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

  • Hyperbaric oxygen (2.0 ATA + NBH)

    Drug

    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

  • Hyperbaric oxygen (2.5 ATA + NBH)

    Drug

    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

  • Normobaric Hyperoxia (NBH)

    Drug

    100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead

  • Usual Care

    Other intervention

    Will be treated with usual and customary care for severe traumatic brain injury

Treatment groups

200 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Hyperbaric oxygen (1.5 ATA, no NBH)Experimental treatment 1 intervention
Group B: Hyperbaric oxygen (2.0 ATA, no NBH)Experimental treatment 1 intervention
Group C: Hyperbaric oxygen (2.5 ATA, no NBH)Experimental treatment 1 intervention
Group D: Hyperbaric oxygen (1.5 ATA + NBH)Experimental treatment 1 intervention
Group E: Hyperbaric oxygen (2.0 ATA + NBH)Experimental treatment 1 intervention
Group F: Hyperbaric oxygen (2.5 ATA + NBH)Experimental treatment 1 intervention
Group G: Normobaric Hyperoxia (NBH)Experimental treatment 1 intervention
Group H: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glasgow Outcome Scale Extended (GOS-E)

Time frame
Assessment at 6 months

Secondary outcomes

1

Duration of ICP elevation

The duration of ICP elevation will be measured using the area under the curve methodology

Time frame
First 5 days
2

Therapeutic intensity level scores for controlling intracranial pressure (ICP)

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

Time frame
First 5 days
3

Brain tissue partial pressure of oxygen

This outcome will be measured only in patients with LICOX monitoring

Time frame
First 5 days
4

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

Time frame
180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gaylan Rockswold

Lead sponsor

Hennepin Healthcare Research Institute

Sponsor institution

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Strategies to Innovate EmeRgENcy Care Clinical Trials Network

Collaborator

Source ClinicalTrials.gov
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