Hyperbaric oxygen treatment for severe brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial aims to identify the optimal parameters for hyperbaric oxygen (HBO2) treatment in patients with severe traumatic brain injury (TBI). The study will evaluate various combinations of pressure levels and the potential enhancement of treatment effectiveness through the use of non-breathing hyperbaric (NBH) techniques. By determining the most effective HBO2 treatment parameters, the trial seeks to provide critical data for a future definitive efficacy trial. The focus is on minimizing oxygen toxicity while maximizing therapeutic benefits for patients.

Why it matters

Who can join: the full rules

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

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

Where it's running

• UCSD Medical Center - Hillcrest Hospital
  San Diego, California, United States Recruiting
• St. Mary's Medical Center
  West Palm Beach, Florida, United States Recruiting
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting
• University of Kentucky Hospital
  Lexington, Kentucky, United States Recruiting
• University of Maryland
  Baltimore, Maryland, United States Recruiting
• Detroit Receiving Hospital
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: Gaylan L Rockswold, M.D., Ph.D. — Hennepin County Medical Center, Minneapolis
• Study coordinator: Gaylan L. Rockswold, M.D., Ph.D.
• Email: gaylan.rockswold@hcmed.org
• Phone: 612-873-2810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.