TBI is sudden damage to the brain caused by an outside force to the head. TBI can affect a person’s ability to think and remember things, and may cause permanent brain damage or even death.
Clinical researchers usually obtain consent before a person participates in a research study. However, in traumatic brain injury, the patient may be severely injured or unconscious and be unable to provide their consent. In such a circumstance, the researchers will try to identify the person's legal guardian (usually next of kin) for consent.
However, research shows that TBI must be treated as quickly as possible, and therefore there might not be enough time to obtain consent before the study strategies are started. Once family is located, they will be asked for permission for the patient to continue in the study. A special set of government rules allow research studies to include patients with an “exception from informed consent” under these circumstances.
This is only allowed in life threatening circumstances, where the best strategy is unknown or unproven, when there is a potential benefit to participants, and when it is not possible to get consent from the patients’ families or representatives before the study strategies need to begin. Once the family or legal representative is located, they will be asked whether they want the patient to continue in the study.
The BOOST3 study compares two alternative strategies of treating patients with brain injury in the intensive care unit. Both are currently used in standard care, but physicians do not know which strategy is better. Neither treatment being studied are investigational. The study will determine the safety and effectiveness of medical care based on monitoring both intracranial pressure (ICP) and brain tissue oxygen as compared to care based on ICP monitoring alone in the ICU.. The results of the study will help doctors learn if one way of treating future victims of TBI is better.
Eligible patients will be randomized as soon as ICP and oxygen probes are placed, but no longer than six hours of arriving at the hospital and no longer than 12 hours from injury. All BOOST3 participants will be followed for six months, and investigators will compare the functional outcomes and neurological function of the two groups.
Ohio State Wexner Medical Center and OhioHealth Riverside Methodist Hospital will attend community meetings to provide information about this study, answer questions and hear community feedback. Neuro-critical care specialists leading this research – Dr. Shraddha Mainali and Dr. John McGregor of Ohio State and Dr. Chad Miller of OhioHealth – will conduct an online survey seeking community feedback at http://bit.ly/BOOST3CommunitySurvey.
Anyone who does not want to be included in this clinical trial can opt out. Contact study co-coordinator Mohammad Hamed at Ohio State Wexner Medical Center at firstname.lastname@example.org
, 614-688-6681 or Marie Brown at Riverside Methodist Hospital, Marie.Brown@ohiohealth.com
614-566-1277 to request an “Opt Out” medical alert bracelet. Wearing this “BOOST3 declined” medical alert bracelet throughout the five-year study period will communicate a person’s wishes not to participate in case they suffer a severe TBI and are unconscious.
Patients who don’t participate in the study will receive the standard medical treatment provided for traumatic brain injuries. For more information on BOOST-3, visit boost3trial.org
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