Public Service Announcement: UC Department of Neurosurgery Seeks Public Input Regarding Investigational Hypothermia Treatment for Blood Clot on the Brain due to Trauma

New investigational research treatment for traumatic brain injury
We are seeking public input before launching a research study aimed at improving the odds that patients who suffer severe traumatic brain injury with a subdural hematoma (blood clot on the brain) will go on to live a normal life. The randomized clinical trial will assess whether maintaining a moderately low body temperature, known as hypothermia, will improve the mental and physical outcomes in these patients.

Waiver of consent
Patients suffering severe head injuries are unconscious and unable to provide their consent to participate in a research therapy trial. Federal law requires us to gather public comment before the study begins because physicians in some cases need to proceed with emergency treatment before the opportunity to obtain consent. Federal law established the “waiver of consent” in 1996 so that physicians could begin emergency experimental treatment after injury before obtaining consent from the patient or from a legal guardian or family member. Under terms of the hypothermia study, patients with a blood clot on the brain due to severe head injury will be evaluated by a neurosurgeon in the emergency room to determine if the patient meets criteria for inclusion in the study. If so, the patient would be randomized to body temperature management at either normal temperature or hypothermia.

How you can help
To qualify for the waiver of consent, our researchers are informing the public about this new research treatment through the news media, press releases, and lectures to local community groups. You can help by first understanding how the research treatment is conducted (learn about hypothermia), then please take a moment to complete a short accompanying survey.

For more information, please contact at 513-558-3546 or email us at clinicaltrials@mayfieldclinic.com

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