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Brain Oxygen Optimization in Severe TBI, Phase 3
Sponsor: University of Michigan
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1094
Start Date
2019-08-28
Completion Date
2027-11-01
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
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.
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 (54)
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
University of Michigan
Ann Arbor, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, United States
Cooper University Hospital
Camden, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Kings County Hospital Center
Brooklyn, New York, United States
North Shore University Hospital
Manhasset, New York, United States
NYP Columbia University Medical Center
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Parkland Hospital
Dallas, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada
St. Michaels Hospital
Toronto, Ontario, Canada
CIUSSS-NIM Hopital du Sacre - Coeur de Montreal
Montreal, Canada