Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
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.
Condition:
Traumatic Brain Injury
Treatment:
Hyperbaric oxygen (1.5 ATA, no NBH)
Start Date:
June 25, 2018
Sponsor:
Hennepin Healthcare Research Institute
For More Information:
https://clinicaltrials.gov/show/NCT02407028