COLUMBUS, Ohio – Traumatic brain injury is the leading cause of death and disability in children and adults up to age 44. Every 15 seconds, someone in the United States suffers a major traumatic brain injury, and every five minutes someone is forever disabled from traumatic brain injury (TBI).
Researchers at The Ohio State University Wexner Medical Center and College of Medicine are conducting an emergency medicine study to identify the best method and concentration of oxygen delivery to patients with severe blunt head trauma to facilitate recovery. All patients will receive standard of care for their TBI in addition to various modes of oxygen concentration and delivery under normal pressure or high pressure (hyperbaric oxygen therapy).
Hyperbaric oxygen therapy is a standard approved therapy for other conditions, but not yet for patients with severe TBI. The Hyperbaric Oxygen Brain Injury Treatment trial (HOBIT) is investigational, which means it hasn’t been approved by the U.S. Food and Drug Administration for use outside of research studies like this one. It’s unknown if adding hyperbaric oxygen therapy to standard of care in TBI patients is more effective, less effective or the same as standard of care alone.
The study will include adults and children ages 16–65 with severe brain injury requiring admission to the intensive care unit with brain monitoring. Hospitals across the country are conducting the study that’s funded by the National Institutes of Health.
Clinical researchers usually obtain consent before a person participates in a research study. However, the participants in this study will be severely injured or unconscious, and hence are unable to provide their own consent.
Because head injury is a life-threatening condition requiring immediate, time-sensitive treatment, patients may be enrolled without consent if a family member or a representative cannot be located.
Under special circumstances, a specific set of government rules allows research studies to include patients with an “exception from informed consent (EFIC).” The EFIC is allowed for life-threatening circumstances, when the best strategy is unknown or unproven, there is a potential benefit to participants and it’s not possible to obtain consent from the patients’ families or representatives before the study strategies need to begin.
The investigator team will make every attempt to locate family prior to enrollment. If the patient is enrolled in the study under EFIC, without consent, the investigator team will continue efforts to locate family or legally authorized representative to seek permission for the patient to continue in the study.
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