The UNC Medical Center will soon begin a study of the emergency treatment of patients with severe traumatic brain injury (TBI) that compares two treatments routinely used for monitoring and treating children over the age of 14 and adults with severe TBI in the Neuroscience Intensive Care Unit (NSICU). The study is called Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3), and it is sponsored by the National Institutes of Health (NIH).
Patients eligible for BOOST-3 will be comatose and unable to tell doctors whether they wish to be included the study. A special set of government rules allows studies to include patients with an Exception From Informed Consent (EFIC) under these circumstances. EFIC is only allowed in life threatening situations:
- where the best treatment is not known;
- when there is the possibility of benefit for participants, and
- when it is not possible to get consent from the patient, the patient’s family or representatives before the study treatment needs to start.
Approval for EFIC is granted only when substantial community input and public disclosure is accomplished. That includes community outreach such as emails, news articles, web postings, focus groups and other activities. We are currently in the disclosure phase and informing the general public about the upcoming study.
- For more information about the trial please visit this website.
- If you would like to share your thoughts about the study or do not want to be included (opt out) from the study, please visit the online survey.
- For updated information, you can visit our Facebook page.
Feel free to share this information with any interested parties. Please refer questions to the study team listed below.
Dr. Rhonda Cadena or Luigi Troiani, PA
Text or call: (919) 283-9281