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RECRUITINGINTERVENTIONAL

Brain Oxygen Optimization in Severe TBI, Phase 3

Brain Oxygen Optimization in Severe TBI (BOOST3): A Comparative Effectiveness Study to Test the Efficacy of a Prescribed Treatment Protocol Based on Monitoring the Partial Pressure of Brain Tissue Oxygen.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Non-penetrating traumatic brain injury - Glasgow Coma Scale (GCS) 3-8 measured off paralytics - Glasgow Coma Scale motor score \< 6 if endotracheally intubated - Evidence of intracranial trauma on CT scan - Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital - Able to place intracranial probes and randomize within 12 hours from injury - Age greater than or equal to 14 years Who Should NOT Join This Trial: - Non-survivable injury - Bilaterally absent pupillary response in the absence of paralytic medication - Contraindication to the placement of intracranial probes - Treatment of brain tissue oxygen values prior to randomization - Planned use of devices which may unblind treating physicians to brain tissue hypoxia - Systemic sepsis at screening - Refractory hypotension - Refractory systemic hypoxia - PaO2/FiO2 ratio \< 150 - Known pre-existing neurologic disease with confounding residual neurological deficits - Known inability to perform activities of daily living (ADL) without assistance prior to injury - Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments - Pregnancy - Prisoner - On EFIC Opt-Out list as indicated by a bracelet or medical alert Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Non-penetrating traumatic brain injury * Glasgow Coma Scale (GCS) 3-8 measured off paralytics * Glasgow Coma Scale motor score \< 6 if endotracheally intubated * Evidence of intracranial trauma on CT scan * Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital * Able to place intracranial probes and randomize within 12 hours from injury * Age greater than or equal to 14 years Exclusion Criteria: * Non-survivable injury * Bilaterally absent pupillary response in the absence of paralytic medication * Contraindication to the placement of intracranial probes * Treatment of brain tissue oxygen values prior to randomization * Planned use of devices which may unblind treating physicians to brain tissue hypoxia * Systemic sepsis at screening * Refractory hypotension * Refractory systemic hypoxia * PaO2/FiO2 ratio \< 150 * Known pre-existing neurologic disease with confounding residual neurological deficits * Known inability to perform activities of daily living (ADL) without assistance prior to injury * Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments * Pregnancy * Prisoner * On EFIC Opt-Out list as indicated by a bracelet or medical alert

Treatments Being Tested

OTHER

ICP + PbtO2 guided management strategy

In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg and to avoid PbtO2 dropping below 20 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada for patients with severe TBI. The devices are used in standard care at hospitals participating in this research study. Doctors adjust their treatment choices to try to achieve these ICP and PbtO2 goals. 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. This management strategy is used to guide care for 5 days in this research study.

OTHER

ICP guided management strategy

In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull, but PbtO2 is not used to guide care. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada, and are routinely used in patients with severe TBI. Doctors adjust their treatment choices to try to achieve this ICP goal. 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. This management strategy is used to guide care for 5 days in this research study.

Locations (20)

Cedars-Sinai Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
San Francisco General Hospital
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
University of Chicago Medical Center
Chicago, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States