Health Trials

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

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

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

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