STUDY DESCRIPTION

Overview of BOOST-3

The University of Pittsburgh are joining researchers at approximately 45 other hospitals across the country to conduct a traumatic brain injury study called BOOST-3.  This study may affect you or someone you know and we need to find out ahead of time what the residents of Pittsburgh and the surroundings areas think about it. 

 

Traumatic brain injury, also known as T.B.I., is an injury to the brain caused by an outside force such as during a fall or a car accident.  TBI can be a life threatening medical emergency and is the leading cause of death among people one to forty-four years old.   In the United States, about 1.4 million people suffer a TBI each year and about 50,000 people die. No new treatments have been developed in over 30 years.

 

The BOOST-3 study wants to learn if treating low brain oxygen, in addition to controlling pressure inside the brain, will work better than standard medical care alone in reducing the brain damage caused by a traumatic brain injury. 

  

A review of data from previous studies revealed that TBI patients who received treatment for low brain oxygen, in addition to treatment for increased brain pressure, was safe? had improved neurologic outcomes compared to patients treated for increased brain pressure alone.

 

In this study, treatment will be randomized (similar to flipping a coin).  There is a 50/50 chance that patients be randomly entered into one of two groups: those who receive a treatment protocol based on brain pressure monitoring alone or the combination of brain pressure and brain oxygen monitoring.

All medical treatments and all research contain risks. These risks are the same whether or not patients participate in the study.  The risks of treating low brain oxygen or increased brain pressure include pneumonia, lung injury, infection, and slight bleeding at the insertion site of the monitors.

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The benefit that may reasonably be expected from participating in this study is reduced brain damage caused by traumatic brain injury and improved brain function six months after the injury from treating low brain oxygen, but these benefits may or may not occur.  Further, this study may result in improved treatment for traumatic brain injury patients in the future.

 

The potential beneficial effects are greatest if the treatment protocol is begun for TBI patients as soon as possible after the injury.  Severe TBI patients are unconscious and there is no way to ask them if they agree to participate in this study.  Regulations allow emergency research, like this study, to be conducted when a person has an emergency medical condition, cannot give informed consent, the experimental treatment holds potential for direct benefit to the patient, and the treatment must be started quickly.

 

Patients and their families will be told about their participation receiving treatment for low brain oxygen as per study protocol at the earliest opportunity after they arrive at the hospital.  The researchers will ask them if they agree to continue.  Continuing in the study will involve talking to doctors, being monitored for changes in their health, and returning after 6 months so doctors can check on their recovery.

 

Community members who do not want to be in the study may send an email that tells doctors they do not want to be in the study. 

 

We would now like to ask your opinion about this research.
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