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Optimisation de l'oxygène cérébral dans les traumatismes crâniens graves, phase 3 (BOOST3)

6 novembre 2026 mis à jour par: William Barsan, University of Michigan

Brain Oxygen Optimization in Severe TBI (BOOST3): Une étude d'efficacité comparative pour tester l'efficacité d'un protocole de traitement prescrit basé sur la surveillance de la pression partielle d'oxygène des tissus cérébraux.

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

1094

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

14 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Autre: 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.
Comparateur actif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Glasgow Outcome Scale-Extended (GOS-E)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Survival
Délai: 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
Délai: 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
Délai: 6 months

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

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

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan

Collaborateurs

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

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 août 2019

Achèvement primaire (Estimé)

1 novembre 2027

Achèvement de l'étude (Estimé)

1 novembre 2027

Dates d'inscription aux études

Première soumission

16 novembre 2018

Première soumission répondant aux critères de contrôle qualité

22 novembre 2018

Première publication (Réel)

27 novembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BOOST3
  • U01NS099046 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Délai de partage IPD

1 year after publication on main outcome results paper

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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