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Optymalizacja tlenu w mózgu w ciężkim TBI, faza 3 (BOOST3)

6 listopada 2026 zaktualizowane przez: William Barsan, University of Michigan

Optymalizacja tlenu w mózgu w ciężkim TBI (BOOST3): badanie porównawcze skuteczności w celu przetestowania skuteczności zalecanego protokołu leczenia opartego na monitorowaniu ciśnienia parcjalnego tlenu w tkance mózgowej.

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1094

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

14 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Inny: 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.
Aktywny komparator: 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Glasgow Outcome Scale-Extended (GOS-E)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Survival
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 6 months

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

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

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

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

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Michigan

Współpracownicy

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

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

28 sierpnia 2019

Zakończenie podstawowe (Szacowany)

1 listopada 2027

Ukończenie studiów (Szacowany)

1 listopada 2027

Daty rejestracji na studia

Pierwszy przesłany

16 listopada 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 listopada 2018

Pierwszy wysłany (Rzeczywisty)

27 listopada 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BOOST3
  • U01NS099046 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Ramy czasowe udostępniania IPD

1 year after publication on main outcome results paper

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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