IOWA CITY, Iowa (KWQC) - Could hyperbaric oxygen be used to treat severe traumatic brain injuries? University of Iowa Health Care is trying to find out by joining a national study.
The study is funded by the National Institutes of Health and included 14 other hospitals. The Hyperbaric Oxygen for Brain Injury Treatment study will investigate whether delivering high dose oxygen under pressure to patients with severe traumatic brain injury (TBI) can improve recovery with less disability.
There are currently no effective treatments for severe TBI, which is a leading cause of death and disability in children and adults under age 45. Prior studies have shown that hyperbaric oxygen therapy, a standard approved therapy for other conditions, may also be beneficial in healing TBI.
Because of the circumstances, the study will be using a different consent process, called Exception from Informed Consent (EFIC). Patients with severe traumatic brain injury are unable to decide whether to participate in research, and in some cases, family members or legal representatives cannot be reached quickly enough to offer hyperbaric oxygen as a treatment. In those circumstances, a patient could be enrolled in the trial without a family member or legal representative providing consent using EFIC for emergency research. When possible, patient’s family or legal representatives will be identified to make decisions on behalf of loved ones. Once a family member is located, they will be told about the study and will be asked to give their permission for continued participation
Clinical trials that use EFIC must follow strict U.S. Food and Drug Administration standards and can only be used in a narrow set of circumstances when:
- The person’s life is at risk, and,
- The best treatment is not known, and
- Participation in the study might help the person, and
- It is not possible to get permission from the patient
Anyone interested in learning more about the providing input, or opting out of participation should contact the UI emergency care research team at (319)-384-8335 or EM-Research@uiowa.edu.
Copyright 2021 KWQC. All rights reserved.
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January 30, 2021 at 04:42AM
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University of Iowa joins national study on treating severe brain injury - KWQC
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