Duke Community Members Site
Duke University Hospital is conducting a study of the emergency treatment of patients with severe traumatic brain injury (TBI).
Traumatic Brain Injury (TBI) is sudden damage to the brain caused by an outside force to the head – like a car crash, a fall, or a hit to the head.
Duke University Hospital has joined dozens of other hospitals across North America to find the best treatment options for TBI.
The study will compare two treatments routinely used for monitoring and treating children and adults with severe TBI in the intensive care unit (ICU). The study will find out which treatment is more likely to help patients get better.
The name of the study is the Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST3) study and it is paid for by the National Institutes of Health.
Patients eligible for BOOST3 will be comatose and unable to tell doctors whether they wish to be in the study (give consent). A special set of government rules allows studies to include patients with an “exception from informed consent” under these circumstances.
Exception from informed consent 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
Where can I learn more about this study?
Online at the BOOST3 Trial Website
What if I do not want to be included in the study?
If you decide you do not want to be included if you suffer a future TBI, you can contact us to ask for an Opt Out medical alert bracelet. We will send you a bracelet with the words “BOOST3 declined.” Wearing this bracelet at all times during the study period (about 5 years) is how you will tell the researchers your wishes if you are unconscious from a severe TBI.
If you do not participate in the study, you will get the standard medical treatment given to patients who have traumatic brain injuries at the hospital in your community.
You can find the form here: Boost3 Opt-Out Form
You can submit thoughts and comments via the online survey.
Questions? Concerns? Contact us:
c/o Alexander Limkakeng
DUMC Box 3096
2301 Erwin Road
Durham NC, 27710
Office Phone: 919-681-0907