Wayne State University Medical Center recently issued the following announcement on Nov. 2.
The Department of Emergency Medicine at the Wayne State University School of Medicine is conducting a study with patients presenting with severe traumatic brain injury to the emergency department Detroit Receiving Hospital.
The Hyperbaric Oxygen Brain Injury Treatment Trial, or HOBIT, is being done to learn whether a new study treatment for subjects with TBI is likely to help them get better. The purpose is also to determine the best dose. The treatment being studied is giving 100% oxygen at higher than normal pressures inside a chamber, also called hyperbaric oxygen therapy or HBOT. HBOT is routinely used for other conditions but not in subjects with TBI. It is not known if adding HBOT to the standard care given to TBI patients is more effective, less effective or the same as standard care alone.
This trial is supported and sponsored by the Strategies to Innovate EmeRgENcy Care Clinical Trials Network- Neurologic Emergency Treatment Trials, which is funded by the National Institutes of Neurologic Disease and Stroke.
The patients with severe TBI will be unconscious and unable to say whether or not they want to participate in the study. This type of situation involves Exception from Informed Consent, or EFIC, for emergency research. EFIC for emergency research refers to a special set of rules used by the U.S. government to regulate studies when research participants cannot tell researchers their desires in a medical emergency. These special rules allow research studies in certain emergency situations to be conducted without consent when the person’s life is at risk, the best treatment is not known, the study might help the person and it is not possible to get permission from the person because of his or her medical condition nor from the person’s representative because there is a very short amount of time required to treat the medical problem or the representative is not available.
Original source can be found here.
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