Hyperbaric Oxygen Brain Injury Treatment Trial

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.

Inclusion Criteria:

- Age 16 years or older and 65 years or younger

- Present with severe TBI, defined as 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

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