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Hersenzuurstofoptimalisatie bij ernstig TBI, fase 3 (BOOST3)

6 november 2026 bijgewerkt door: William Barsan, University of Michigan

Brain Oxygen Optimization in Severe TBI (BOOST3): een vergelijkende effectiviteitsstudie om de werkzaamheid van een voorgeschreven behandelingsprotocol te testen op basis van monitoring van de partiële druk van hersenweefselzuurstof.

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1094

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
      • Montreal, Canada, H4J 1C5
        • CIUSSS-NIM Hopital du Sacre - Coeur de Montreal
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary - Foothills Medical Centre
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michaels Hospital
  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Verenigde Staten, 90095-7436
        • Ronald Reagan UCLA Medical Center
      • Palo Alto, California, Verenigde Staten, 94305
        • Stanford University Medical Center
      • Sacramento, California, Verenigde Staten, 95817
        • UC Davis Medical Center
      • San Francisco, California, Verenigde Staten, 94143
        • San Francisco General Hospital
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • University of Colorado Hospital
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06510
        • Yale New Haven Hospital
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32608
        • UF Health Shands Hospital
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30303
        • Grady Memorial Hospital
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46260
        • St. Vincent Hospital
    • Maine
      • Portland, Maine, Verenigde Staten, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, Verenigde Staten, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Verenigde Staten, 02128
        • Massachusetts General Hospital
      • Worcester, Massachusetts, Verenigde Staten, 01655
        • UMASS Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan
      • Detroit, Michigan, Verenigde Staten, 48201
        • Detroit Receiving Hospital
      • Detroit, Michigan, Verenigde Staten, 48201
        • Henry Ford Hospital
    • Minnesota
      • Saint Paul, Minnesota, Verenigde Staten, 55101
        • Regions Hospital
    • New Jersey
      • Camden, New Jersey, Verenigde Staten, 08103
        • Cooper University Hospital
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87131
        • University of New Mexico Hospital
    • New York
      • Flushing, New York, Verenigde Staten, 11355
        • NewYork-Presbyterian Queens Hospital
      • Manhasset, New York, Verenigde Staten, 11030
        • North Shore University Hospital
      • New York, New York, Verenigde Staten, 10032
        • NYP Columbia University Medical Center
      • Rochester, New York, Verenigde Staten, 14642
        • Strong Memorial Hospital
      • Syracuse, New York, Verenigde Staten, 13210
        • SUNY Upstate Medical University
      • The Bronx, New York, Verenigde Staten, 10461
        • Jacobi Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • University of North Carolina Medical Center
      • Durham, North Carolina, Verenigde Staten, 27710
        • Duke University Hospital
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45219
        • University of Cincinnati Medical Center
      • Columbus, Ohio, Verenigde Staten, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Verenigde Staten, 43210
        • OSU Wexner Medical Center
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Oregon Health & Science University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15212
        • UPMC Presbyterian Hospital
    • Texas
      • Dallas, Texas, Verenigde Staten, 75235
        • Parkland Hospital
      • Houston, Texas, Verenigde Staten, 77030
        • Ben Taub General Hospital
      • San Antonio, Texas, Verenigde Staten, 78229
        • University of Texas Health Science Center San Antonio
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84132
        • University of Utah Healthcare
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • VCU Medical Center
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Harborview Medical Center
    • West Virginia
      • Morgantown, West Virginia, Verenigde Staten, 26506
        • WVU Healthcare Ruby Memorial Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Froedtert Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

14 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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 < 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: 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.
Actieve vergelijker: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glasgow Outcome Scale-Extended (GOS-E)
Tijdsspanne: 6 months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Survival
Tijdsspanne: At discharge from hospital, an average of 19 days

Survival at discharge from hospital
At discharge from hospital, an average of 19 days
Total Brain Hypoxia Exposure
Tijdsspanne: Inclusive of up to 5 days of study intervention

The cumulative area on the time versus brain tissue oxygenation (PbtO2) curve in which PbtO2 is less than 20 mmHg.
Inclusive of up to 5 days of study intervention
Cognition: Rey Auditory Verbal Learning Test
Tijdsspanne: 6 months

A measure of verbal learning and memory.
6 months
Cognition: Trail Making Test Part A+B
Tijdsspanne: 6 months

A measure of attention, visual-motor tracking and executive functioning.
6 months
Emotional Health: Rivermead Post-Concussion Symptom Questionnaire
Tijdsspanne: 6 months

A measure of the presence and severity of post-concussion somatic, cognitive, and emotional symptoms.
6 months
Emotional Health: Brief Symptom Inventory 18
Tijdsspanne: 6 months

A measure of psychological distress and psychiatric disorders.
6 months
Emotional Health: Satisfaction with Life Scale
Tijdsspanne: 6 months

A measure of global cognitive judgments of one's life satisfaction.
6 months
Functional Status Exam
Tijdsspanne: 6 months

Change in the activities of every day life as a function of a sudden event or illness
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Medewerkers

Medical University of South Carolina
University of Pennsylvania
National Institute of Neurological Disorders and Stroke (NINDS)
University of Pittsburgh
University of Washington

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 augustus 2019

Primaire voltooiing (Geschat)

1 november 2027

Studie voltooiing (Geschat)

1 november 2027

Studieregistratiedata

Eerst ingediend

16 november 2018

Eerst ingediend dat voldeed aan de QC-criteria

22 november 2018

Eerst geplaatst (Werkelijk)

27 november 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BOOST3
  • U01NS099046 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD-tijdsbestek voor delen

1 year after publication on main outcome results paper

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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