BOOST-3 (Proposed Study)

BOOST3 is a randomized clinical trial (NCT03754114) to compare the effectiveness of two strategies for monitoring and treating patients with TBI in the intensive care unit (ICU).  Traumatic brain injury (TBI) is a major cause of death and disability. Every year, approximately 3.5 million Americans sustain a TBI, of whom 50,000 die. Another 300,000 patients are hospitalized and survive the injury. 

The study will compare the safety and efficacy of a treatment strategy guided by both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) monitoring versus a strategy guided by ICP monitoring alone.  Both of these strategies are used in usual care by different doctors and institutions. It is unknown if one strategy is more effective than the other for improving patient recovery. 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.

Patients who are eligible for this study will be 14 years of age or older and have a severe TBI (unconscious).  Patients arriving to a participating hospital within a few hours of their injury are eligible.  Patients in this situation typically have some brain monitoring as part of usual care.  Because patients will not be awake to provide consent and rapid treatment of TBI is essential for survival, this trial may begin under Exception from Informed Consent until family can be located.   The results of this trial will help doctors determine which brain monitors are most useful.