Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1094 participants
INTERVENTIONAL
2019-08-28
2027-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICP only
ICP guided management strategy: Care in the ICU of research participants randomized to this arm will be guided by a monitoring and treatment strategy in which doctors try to prevent high intracranial pressure (ICP) caused by a swollen brain. This strategy is one of two alternative strategies that is currently used in standard care of patients with traumatic brain injury.
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.
ICP + PbtO2
ICP + PbtO2 guided management strategy: Care in the ICU of research participants randomized to this arm will be guided by a monitoring and treatment strategy in which doctors try to prevent high intracranial pressure (ICP), and also try to prevent low PbtO2 (brain tissue oxygen levels). This strategy is one of two alternative strategies that is currently used in standard care of patients with traumatic brain injury.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Washington
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
Medical University of South Carolina
OTHER
University of Michigan
OTHER
Responsible Party
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William Barsan
Professor of Emergency Medicine
Principal Investigators
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Lori Shutter, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh, Pittsburgh, PA 15260
Ramon Diaz-Arrastia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania, Philadelphia, PA 19104
William Barsan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan, Ann Arbor, MI 48109
Sharon Yeatts, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina, Charleston, SC 29425
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Maranatha Ayodele
Role: primary
Karen Hirsch
Role: primary
Lara Zimmermann, MD
Role: primary
Emily Gilmore, MD
Role: primary
Christopher Robinson
Role: primary
Jonathan Ratcliff, MD
Role: primary
Christos Lazaridis, MD
Role: primary
Richard Rodgers, MD
Role: primary
Teresa May, MD
Role: primary
Bradley Molyneaux, MD, PhD
Role: primary
Raphael Carandang
Role: primary
Venkatakrishna Rajajee
Role: primary
Wazim Mohamed, MD
Role: primary
Christopher Lewandowski, MD
Role: primary
Alan Turtz, MD
Role: primary
Huy Tran, MD
Role: primary
Tania Rebeiz
Role: primary
Nrupen Baxi, MD
Role: primary
Matthew Sharrock
Role: primary
Katharine Colton, MD
Role: primary
Natalie Kreitzer
Role: primary
Mhdezzat Zaghlouleh, MD
Role: primary
Danielle Sandsmark
Role: primary
Jack Jallo, MD
Role: primary
David Okonkwo, MD
Role: primary
Stephen Figueroa
Role: primary
Jovany Cruz, MD
Role: primary
Michael McGinity
Role: primary
Holly Ledyard
Role: primary
Ramani Balu, MD
Role: primary
Lisa Merck
Role: primary
Randall Chesnut
Role: primary
Gregory Rozansky
Role: primary
Andrea Rigamonti
Role: primary
Francis Bernard, MD
Role: primary
References
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Okonkwo DO, Shutter LA, Moore C, Temkin NR, Puccio AM, Madden CJ, Andaluz N, Chesnut RM, Bullock MR, Grant GA, McGregor J, Weaver M, Jallo J, LeRoux PD, Moberg D, Barber J, Lazaridis C, Diaz-Arrastia RR. Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial. Crit Care Med. 2017 Nov;45(11):1907-1914. doi: 10.1097/CCM.0000000000002619.
Bernard F, Barsan W, Diaz-Arrastia R, Merck LH, Yeatts S, Shutter LA. Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3): a multicentre, randomised, blinded-endpoint, comparative effectiveness study of brain tissue oxygen and intracranial pressure monitoring versus intracranial pressure alone. BMJ Open. 2022 Mar 10;12(3):e060188. doi: 10.1136/bmjopen-2021-060188.
Fiore M, Bogossian E, Creteur J, Oddo M, Taccone FS. Role of brain tissue oxygenation (PbtO2) in the management of subarachnoid haemorrhage: a scoping review protocol. BMJ Open. 2020 Sep 15;10(9):e035521. doi: 10.1136/bmjopen-2019-035521.
Related Links
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BOOST3 Study Website
Other Identifiers
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BOOST3
Identifier Type: -
Identifier Source: org_study_id
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