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).
When a person has a TBI, their injured brain can swell over a period of hours or days. If
the brain swells too much, the pressure in the skull increases and becomes dangerous,
causing further injury to the brain. To try to prevent this, doctors usually insert a
device, an ICP monitor, into the brain through a hole in the skull of people with severe
TBI. An ICP monitor measures the pressure inside the skull. Most doctors agree that it is
important to measure and prevent high ICP. Patients with injured brains also suffer
additional injury to the brain if the amount of oxygen in the brain gets too low. Some
doctors also insert a second device, a PbtO2 monitor, in the brain through the same or a
second hole in the skull to measure brain tissue oxygen. A PbtO2 monitor measures how
much oxygen is in a small area of the brain near the tip of the monitor. Other doctors
think this is unnecessary and unhelpful. Both monitoring devices are approved by the US
Food and Drug Administration (FDA) and Health Canada for patients with TBI. Both are
commonly used. The ICP and PbtO2 goals guided by these monitors are used to help doctors
adjust their treatment choices. Treatments include kinds and doses of medications and the
amount of intravenous fluids given, ventilator (breathing machine) settings, need for
blood transfusions, and other medical care. Each of these treatment decisions is intended
to improve outcomes. However, each treatment decision also involves potential risks.
Different treatment decisions may result in different risks. This study will also help
doctors better understand these risks. This study is funded by the National Institutes of
Health because it answers questions important to the care of patients with TBI.
This study is a two-arm, single-blind, randomized, controlled, phase III, multi-center
trial of ICU monitoring and treatment strategies for patients with severe TBI. It will
compare the efficacy of ICU care guided by PbtO2 and ICP monitoring versus monitoring of
ICP alone in the first 5 days after injury. Only subjects who have severe TBI and require
invasive monitoring, according to Brain Trauma Foundation (BTF) and American College of
Surgeons-Trauma Quality Improvement (ACS TQIP) guidelines, will be enrolled. All
participants in this study will have both ICP monitors and PbtO2 monitors. Half of the
participants will be randomized to an arm that includes treatment informed by PbtO2 and
ICP, and half will be randomized to an arm that treats only ICP.
The PbtO2 values of those in the ICP only arm will be masked, so that the treating
physicians will not be guided by PbtO2 information. Participants in the PbtO2 and ICP arm
will have PbtO2 monitored and low measurements treated. Treatments to address
physiological goals in both arms will follow a clinical standardization plan.
Participants will be followed for 6 months and occurrence of serious adverse events or
death will be recorded. Participants will have a follow-up interview to assess their
level of recovery approximately 6 months post injury.
To reduce the likelihood of imbalance of important prognostic factors between groups, a
covariate-adjusted randomization scheme will be used in this study. Adjustment variables
are clinical site and probability of a poor outcome as defined by the IMPACT core model.
