RECRUITING

Brain Oxygen Optimization in Severe TBI, Phase 3

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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.

Quick Facts

Study Start:2019-08-28
Study Completion:2027-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03754114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Non-penetrating traumatic brain injury
  2. * Glasgow Coma Scale (GCS) 3-8 measured off paralytics
  3. * Glasgow Coma Scale motor score \< 6 if endotracheally intubated
  4. * Evidence of intracranial trauma on CT scan
  5. * Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital
  6. * Able to place intracranial probes and randomize within 12 hours from injury
  7. * Age greater than or equal to 14 years
  1. * Non-survivable injury
  2. * Bilaterally absent pupillary response in the absence of paralytic medication
  3. * Contraindication to the placement of intracranial probes
  4. * Treatment of brain tissue oxygen values prior to randomization
  5. * Planned use of devices which may unblind treating physicians to brain tissue hypoxia
  6. * Systemic sepsis at screening
  7. * Refractory hypotension
  8. * Refractory systemic hypoxia
  9. * PaO2/FiO2 ratio \< 200
  10. * Known pre-existing neurologic disease with confounding residual neurological deficits
  11. * Known inability to perform activities of daily living (ADL) without assistance prior to injury
  12. * Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments
  13. * Pregnancy
  14. * Prisoner
  15. * On EFIC Opt-Out list as indicated by a bracelet or medical alert

Contacts and Locations

Study Contact

William Barsan, MD
CONTACT
734-232-2141
wbarsan@umich.edu
William J Meurer, MD
CONTACT
734-232-2141
wmeurer@umich.edu

Principal Investigator

Lori Shutter, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh, Pittsburgh, PA 15260
Ramon Diaz-Arrastia, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania, Philadelphia, PA 19104
William Barsan, MD
PRINCIPAL_INVESTIGATOR
University of Michigan, Ann Arbor, MI 48109
Sharon Yeatts, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina, Charleston, SC 29425

Study Locations (Sites)

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
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
UF Health Shands Hospital
Gainesville, Florida, 32608
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Maine Medical Center
Portland, Maine, 04102
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
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
Kings County Hospital Center
Brooklyn, New York, 11203
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
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
Memorial Hermann Hospital
Houston, Texas, 77024
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

Collaborators and Investigators

Sponsor: University of Michigan

  • Lori Shutter, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh, Pittsburgh, PA 15260
  • Ramon Diaz-Arrastia, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania, Philadelphia, PA 19104
  • William Barsan, MD, PRINCIPAL_INVESTIGATOR, University of Michigan, Ann Arbor, MI 48109
  • Sharon Yeatts, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina, Charleston, SC 29425

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-28
Study Completion Date2027-11-01

Study Record Updates

Study Start Date2019-08-28
Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

  • intracranial pressure
  • hypoxia, brain
  • critical care
  • emergency treatment
  • monitoring, physiologic

Additional Relevant MeSH Terms

  • Brain Injuries, Traumatic