Traumatic Brain Injury Research Consent
Tomorrow’s medicine starts with today’s patients: Our research could help patients suffering from brain injuries.
A traumatic brain injury (TBI) is sudden damage to the brain caused by an outside force, such as a car crash or a bad fall. A severe TBI causes a patient to be in a coma at the time of their admission to the hospital. In the following hours and days after the event, severe TBI patients are at risk for additional brain injury. Research helps us determine which treatments create the best outcomes for our patients. That’s why our doctors and researchers are conducting a study called BOOST3 to nd better ways to treat TBI.
About the study
BOOST3 is a research study that aims to identify if one of two care plans for treating severe TBI is more effective. Participants in the study will be randomly assigned by a computer to one of the two treatment paths. Both options have already been shown to be safe.
The two treatments being studied are:
Medical care based on monitoring of pressure in the brain alone – The care team focuses on preventing high pressure in the brain, known as intracranial pressure (ICP). This is the usual treatment for severe TBI.
Medical care based on both Intracranial Pressure (ICP) and the level of oxygen in the brain – The care team tries to prevent high ICP, while also trying to prevent low brain oxygen.
Eligibility for the study
To be eligible for the BOOST3 study, patients must:
- Be 14 years of age or older
- Have a blunt closed head injury
- Have a severe traumatic brain injury
- Have an injury that requires brain pressure monitoring
- Brain pressure monitoring is initiated within twelve hours of the injury and six hours of arrival to Strong Memorial Hospital.
Patients who meet these criteria can be entered into the study at the time of brain monitor placement.
A person with a severe TBI will not be able to give consent at the time of injury.
Since brain injuries happen suddenly and need rapid treatment, a patient may be entered into the study before a family member can be contacted to discuss participation. This is called Exception from Informed Consent (EFIC).
Once we are able to contact the patient’s family or legal representative, we will ask them whether the patient may continue to participate in the study.
Contact us with questions or to ask about opting out of participation