Brain Oxygen Optimization in Severe TBI, Phase 3
BOOST3
2 other identifiers
interventional
1,094
2 countries
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
May 5, 2026
April 1, 2026
8.2 years
November 16, 2018
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glasgow Outcome Scale-Extended (GOS-E)
The Glasgow Outcome Scale-Extended (GOS-E) is a global scale for functional outcome, in which higher scores indicate better outcomes. The GOS-E rates patient status into one of eight categories. A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. The categories of severe disability, moderate disability and good recovery are subdivided into a lower and upper category. All injury related disabilities are assessed.
6 months
Secondary Outcomes (8)
Survival
At discharge from hospital, an average of 19 days
Total Brain Hypoxia Exposure
Inclusive of up to 5 days of study intervention
Cognition: Rey Auditory Verbal Learning Test
6 months
Cognition: Trail Making Test Part A+B
6 months
Emotional Health: Rivermead Post-Concussion Symptom Questionnaire
6 months
- +3 more secondary outcomes
Study Arms (2)
ICP only
ACTIVE COMPARATORICP 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 + PbtO2
ACTIVE COMPARATORICP + 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.
Interventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of South Carolinacollaborator
- University of Michiganlead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- University of Washingtoncollaborator
- University of Pennsylvaniacollaborator
- University of Pittsburghcollaborator
Study Sites (51)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095-7436, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
San Francisco General Hospital
San Francisco, California, 94143, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
UF Health Shands Hospital
Gainesville, Florida, 32608, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02128, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48201, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87131, United States
NewYork-Presbyterian Queens Hospital
Flushing, New York, 11355, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
NYP Columbia University Medical Center
New York, New York, 10032, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15212, United States
Parkland Hospital
Dallas, Texas, 75235, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229, United States
University of Utah Healthcare
Salt Lake City, Utah, 84132, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
University of Calgary - Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
St. Michaels Hospital
Toronto, Ontario, M5B 1W8, Canada
CIUSSS-NIM Hopital du Sacre - Coeur de Montreal
Montreal, H4J 1C5, Canada
Related Publications (3)
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.
PMID: 29028696BACKGROUNDBernard 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.
PMID: 35273066DERIVEDFiore 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.
PMID: 32933956DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Shutter, MD
University of Pittsburgh, Pittsburgh, PA 15260
- PRINCIPAL INVESTIGATOR
Ramon Diaz-Arrastia, MD, PhD
University of Pennsylvania, Philadelphia, PA 19104
- PRINCIPAL INVESTIGATOR
William Barsan, MD
University of Michigan, Ann Arbor, MI 48109
- PRINCIPAL INVESTIGATOR
Sharon Yeatts, PhD
Medical University of South Carolina, Charleston, SC 29425
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessors will be blinded to the treatment assignment of the participant.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Emergency Medicine
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 27, 2018
Study Start
August 28, 2019
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 1 year after publication on main outcome results paper