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Brain Oxygen Optimization in Severe TBI, Phase 3 (BOOST3)

Primary Purpose

Brain Injuries, Traumatic

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ICP + PbtO2 guided management strategy
ICP guided management strategy
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic focused on measuring intracranial pressure, hypoxia, brain, critical care, emergency treatment, monitoring, physiologic

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 < 200
  • 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

Sites / Locations

  • Ronald Reagan UCLA Medical CenterRecruiting
  • Stanford University Medical CenterRecruiting
  • UC Davis Medical CenterRecruiting
  • San Francisco General HospitalRecruiting
  • University of Colorado HospitalRecruiting
  • Yale New Haven HospitalRecruiting
  • UF Health Shands HospitalRecruiting
  • University of Chicago Medical CenterRecruiting
  • Maine Medical CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • UMASS Memorial Medical CenterRecruiting
  • Detroit Receiving HospitalRecruiting
  • Henry Ford HospitalRecruiting
  • Regions HospitalRecruiting
  • Cooper University HospitalRecruiting
  • University of New Mexico HospitalRecruiting
  • North Shore University HospitalRecruiting
  • Strong Memorial HospitalRecruiting
  • University of North Carolina Medical CenterRecruiting
  • Duke University HospitalRecruiting
  • University of Cincinnati Medical CenterRecruiting
  • OSU Wexner Medical CenterRecruiting
  • Riverside Methodist HospitalRecruiting
  • Oregon Health & Science University HospitalRecruiting
  • Penn Presbyterian Medical CenterRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • UPMC Presbyterian HospitalRecruiting
  • Memorial Hermann Hospital
  • Ben Taub General HospitalRecruiting
  • University of Utah HealthcareRecruiting
  • Harborview Medical CenterRecruiting
  • WVU Healthcare Ruby Memorial HospitalRecruiting
  • Froedtert HospitalRecruiting
  • CIUSSS-NIM Hopital du Sacre - Coeur de MontrealRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ICP only

ICP + PbtO2

Arm Description

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 + 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Survival
Survival at discharge from hospital
Total Brain Hypoxia Exposure
The cumulative area on the time versus brain tissue oxygenation (PbtO2) curve in which PbtO2 is less than 20 mmHg.
Cognition: Rey Auditory Verbal Learning Test
A measure of verbal learning and memory.
Cognition: Trail Making Test Part A+B
A measure of attention, visual-motor tracking and executive functioning.
Emotional Health: Rivermead Post-Concussion Symptom Questionnaire
A measure of the presence and severity of post-concussion somatic, cognitive, and emotional symptoms.
Emotional Health: Brief Symptom Inventory 18
A measure of psychological distress and psychiatric disorders.
Emotional Health: Satisfaction with Life Scale
A measure of global cognitive judgments of one's life satisfaction.
Functional Status Exam
Change in the activities of every day life as a function of a sudden event or illness

Full Information

First Posted
November 16, 2018
Last Updated
September 8, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Washington, University of Pennsylvania, University of Pittsburgh, Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03754114
Brief Title
Brain Oxygen Optimization in Severe TBI, Phase 3
Acronym
BOOST3
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
November 1, 2027 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Washington, University of Pennsylvania, University of Pittsburgh, Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic
Keywords
intracranial pressure, hypoxia, brain, critical care, emergency treatment, monitoring, physiologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessors will be blinded to the treatment assignment of the participant.
Allocation
Randomized
Enrollment
1094 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICP only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ICP + PbtO2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ICP + PbtO2 guided management strategy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ICP guided management strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale-Extended (GOS-E)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Survival
Description
Survival at discharge from hospital
Time Frame
At discharge from hospital, an average of 19 days
Title
Total Brain Hypoxia Exposure
Description
The cumulative area on the time versus brain tissue oxygenation (PbtO2) curve in which PbtO2 is less than 20 mmHg.
Time Frame
Inclusive of up to 5 days of study intervention
Title
Cognition: Rey Auditory Verbal Learning Test
Description
A measure of verbal learning and memory.
Time Frame
6 months
Title
Cognition: Trail Making Test Part A+B
Description
A measure of attention, visual-motor tracking and executive functioning.
Time Frame
6 months
Title
Emotional Health: Rivermead Post-Concussion Symptom Questionnaire
Description
A measure of the presence and severity of post-concussion somatic, cognitive, and emotional symptoms.
Time Frame
6 months
Title
Emotional Health: Brief Symptom Inventory 18
Description
A measure of psychological distress and psychiatric disorders.
Time Frame
6 months
Title
Emotional Health: Satisfaction with Life Scale
Description
A measure of global cognitive judgments of one's life satisfaction.
Time Frame
6 months
Title
Functional Status Exam
Description
Change in the activities of every day life as a function of a sudden event or illness
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 < 200 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Barsan, MD
Phone
734-232-2141
Email
wbarsan@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
William J Meurer, MD
Phone
734-232-2141
Email
wmeurer@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Shutter, MD
Organizational Affiliation
University of Pittsburgh, Pittsburgh, PA 15260
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramon Diaz-Arrastia, MD, PhD
Organizational Affiliation
University of Pennsylvania, Philadelphia, PA 19104
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Barsan, MD
Organizational Affiliation
University of Michigan, Ann Arbor, MI 48109
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Yeatts, PhD
Organizational Affiliation
Medical University of South Carolina, Charleston, SC 29425
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Vespa, MD
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Hirsch
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Zimmermann, MD
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude Hemphill
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Neumann
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Gilmore, MD
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Merck, MD
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christos Lazaridis, MD
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa May, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Schweitzer, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Stippler, MD
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Muehlschlegel
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wazim Mohamed, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Lewandowski, MD
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Brogan
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Turtz, MD
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huy Tran, MD
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dAVID lEDOUX, MD
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Zammit
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Cadena, MD
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharine Colton, MD
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Kreitzer
Facility Name
OSU Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shraddha Mainali, MD
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Miller, MD
Facility Name
Oregon Health & Science University Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zonies, MD
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Sandsmark
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Jallo, MD
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Okonkwo, MD
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Robertson, MD
Facility Name
University of Utah Healthcare
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Ledyard
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randall Chesnut
Facility Name
WVU Healthcare Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathaniel Mohney, MD
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Johnson
Facility Name
CIUSSS-NIM Hopital du Sacre - Coeur de Montreal
City
Montréal
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Bernard, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be stored in the NHLBI data repository after trial completion.
IPD Sharing Time Frame
1 year after publication on main outcome results paper
IPD Sharing Access Criteria
Data use agreement with the appropriate NHLBI repository
Citations:
PubMed Identifier
29028696
Citation
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.
Results Reference
background
PubMed Identifier
35273066
Citation
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.
Results Reference
derived
PubMed Identifier
32933956
Citation
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.
Results Reference
derived
Links:
URL
https://siren.network/clinical-trials/boost-3
Description
BOOST3 Study Website

Learn more about this trial

Brain Oxygen Optimization in Severe TBI, Phase 3

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