Brain Oxygen Optimization in Severe TBI, Phase 3

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.

Conditions

Brain Injuries, Traumatic

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Study Overview

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Study Details

Study overview

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.

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.

Brain Oxygen Optimization in Severe TBI, Phase 3

Condition
Brain Injuries, Traumatic
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States, 90095-7436

Palo Alto

Stanford University Medical Center, Palo Alto, California, United States, 94305

Sacramento

UC Davis Medical Center, Sacramento, California, United States, 95817

San Francisco

San Francisco General Hospital, San Francisco, California, United States, 94143

Aurora

University of Colorado Hospital, Aurora, Colorado, United States, 80045

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06510

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Gainesville

UF Health Shands Hospital, Gainesville, Florida, United States, 32608

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

14 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-11-01