Mass General Hospital, Beth Israel Deaconess Medical Center, and UMass Memorial Medical Center are conducting a research study to learn if either of two strategies for monitoring and treating patients with severe traumatic brain injury in the intensive care unit (ICU) is more likely to help them get better. Both of these alternative strategies are used in standard care, but it is unknown if one is more effective than the other.
Traumatic brain injury (TBI) is a major cause of death and disability in developed societies. Every year, approximately 3.5 million Americans sustain a TBI, of which 50,000 die, and another 300,000 are hospitalized and survive the injury. BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU).
The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other.
In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.
Because head injury is a life-threatening condition requiring immediate treatment, some patients will be enrolled without consent if a family member or representative cannot be rapidly available.
Before the study starts, we will consult with the community. We welcome your feedback and questions.
Primary Investigators: Jeffrey Schweitzer, MD, and Joshua Goldstein, MD
Study Coordinator: Chun Mei Su