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Breakthrough Platform Trial for PCAS (BPT-PCAS)

12 августа 2026 г. обновлено: Yasuhiro Kuroda, Kagawa University

Breakthrough Platform Trial for Post Cardiac Arrest Syndrome

The goal of this platform clinical trial is to evaluate whether specific post-cardiac arrest care strategies can improve neurological recovery and survival in adult patients who remain comatose after return of spontaneous circulation (ROSC) following cardiac arrest and require intensive care management.

This multicenter cluster-randomized crossover platform trial (BPT-PCAS) evaluates post-cardiac arrest care strategies within a shared master protocol structure. Participating hospitals are randomized at the institutional level to predefined treatment strategies for fixed study periods and subsequently cross over to alternative strategies according to a predefined allocation schedule.

The platform is designed to accommodate multiple independent intervention domains, each evaluating a different post-cardiac arrest care strategy under shared eligibility criteria, infrastructure, data management systems, and follow-up procedures. Participants may be enrolled in one or more active intervention domains according to platform availability and eligibility.

Participants will receive the post-cardiac arrest care strategy assigned to their participating hospital during the study period while otherwise undergoing standard intensive care management according to local practice and study protocols.

Participants will be followed for neurological outcomes including modified Rankin Scale (mRS), mortality, and safety outcomes at hospital discharge, 30 days, and 90 days after hospital admission.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

BPT-PCAS (Breakthrough Platform Trial for Post-Cardiac Arrest Syndrome) is a multicenter platform trial designed to evaluate whether early post-cardiac arrest care strategies can improve neurological recovery and survival in adult patients who remain comatose after return of spontaneous circulation (ROSC) following cardiac arrest and require intensive care management.

Despite advances in resuscitation and intensive care medicine, prognosis after post-cardiac arrest syndrome (PCAS) remains poor, particularly because of hypoxic-ischemic brain injury and systemic circulatory dysfunction. Many aspects of post-resuscitation intensive care management, including positioning strategies and targeted temperature management, are widely used in clinical practice but remain supported by limited high-quality randomized evidence, particularly during the ultra-early post-ROSC period.

BPT-PCAS is designed as a pragmatic multicenter cluster-randomized crossover platform trial conducted in Japan. Participating hospitals are randomized at the institutional level to predefined treatment strategies for fixed study periods. Hospitals subsequently cross over to alternative treatment strategies every 6 months according to a predefined allocation schedule. Randomization occurs at the hospital level rather than the individual patient level in order to facilitate immediate implementation of time-sensitive post-cardiac arrest interventions during emergency care.

The platform uses a master protocol structure with shared eligibility criteria, infrastructure, data management systems, and follow-up procedures across multiple intervention domains. Adult patients with persistent coma after ROSC who require intensive care are screened for eligibility under the master protocol. Individual domains may apply additional domain-specific inclusion and exclusion criteria.

The current platform includes multiple intervention domains evaluating different post-cardiac arrest care strategies.

One domain evaluates early head positioning strategies during intensive care management. This domain compares head elevation positioning (30°-45°) with near-supine positioning (0°-10°) initiated early after ICU admission in order to determine whether head positioning influences neurological recovery, mortality, and complications associated with cerebral perfusion, intracranial pressure, or respiratory management.

Another domain evaluates early targeted temperature management strategies in patients with non-shockable cardiac arrest rhythms. This domain compares early hypothermia (33-34°C) with normothermia (36-37.5°C) initiated as early as possible after ROSC in order to evaluate whether early temperature control improves neurological outcomes and survival.

Participants may simultaneously participate in more than one intervention domain when eligibility criteria are met. Aside from the assigned study interventions, all other intensive care management is performed according to local institutional practice and study protocols.

The primary and secondary outcomes differ according to each intervention domain and include neurological outcomes assessed using the modified Rankin Scale (mRS), mortality, and predefined safety outcomes. Follow-up assessments are performed during hospitalization and at 30 and 90 days after hospital admission.

Because eligible patients are critically ill and frequently incapable of providing prospective informed consent at the time of enrollment, this study permits deferred consent procedures in accordance with Japanese ethical guidelines for emergency research. Consent from legally acceptable representatives or patients themselves is obtained as soon as feasible after hospital admission whenever possible.

The study also includes predefined interim analyses and centralized data management using REDCap-based electronic data capture systems. Statistical analyses are performed using intention-to-treat principles with methods appropriate for cluster-randomized crossover trial designs.

Тип исследования

Интервенционный

Регистрация (Оцененный)

630

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Yasuhiro Kuroda, M.D, Ph.D
  • Номер телефона: +81-87-891-2392
  • Электронная почта: bpt-pcas@googlegroups.com

Места учебы

  • Япония
    • Chiba
      • Chiba, Chiba, Япония, 2610012
        • Chiba Kaihin Municipal Hospital
        • Контакт:
          • Yosuke Homma
          • Номер телефона: +81-43-277-7711
          • Электронная почта: jazz.dr.homma@gmail.com
    • Fukuoka
      • Iizuka, Fukuoka, Япония, 8208505
        • Aso Iizuka Hospital
        • Контакт:
    • Hiroshima
      • Hiroshima, Hiroshima, Япония, 7348551
        • Hiroshima University Hospital
        • Контакт:
    • Hyōgo
      • Kobe, Hyōgo, Япония, 651-0073
        • Hyogo Emergency Medical Center
        • Контакт:
          • Takeshi Nishimura
          • Номер телефона: +87-78-241-3131
          • Электронная почта: t-nishimura@hemc.jp
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Япония, 761-0701
        • Kagawa University Hospital
        • Контакт:
    • Kyoto
      • Kyoto, Kyoto, Япония, 6158256
        • Kyoto Katsura Hospital
        • Контакт:
          • Taiga Sunada
          • Номер телефона: +81-75-391-5811
          • Электронная почта: sunada.taiga@gmail.com
    • Miyagi
      • Sendai, Miyagi, Япония, 9838520
        • National Hospital Organization Sendai Medical Center
        • Контакт:
    • Okayama-ken
      • Okayama, Okayama-ken, Япония, 7008558
        • Okayama University Hospital
        • Контакт:
    • Saitama
      • Asaka, Saitama, Япония, 3510023
        • TMG Asaka Medical Center
        • Контакт:
    • Tokyo
      • Bunkyō-Ku, Tokyo, Япония, 113-8603
        • Nippon Medical School Hospital
        • Контакт:
          • Toru Takiguchi
          • Номер телефона: +81-3-3822-2131
          • Электронная почта: toru-takiguchi@nms.ac.jp
      • Musashino, Tokyo, Япония, 1800023
        • Musashino Red Cross Hospital
        • Контакт:
      • Sumida-ku, Tokyo, Япония, 1308575
        • Tokyo Metropolitan Bokutoh Hospital
        • Контакт:
          • Kazuhiro Sugiyama
          • Номер телефона: +81-3-3633-6151
          • Электронная почта: kazusugi0422@hotmail.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

Master Platform Eligibility:

  • Adult patients aged 18 years or older
  • Return of spontaneous circulation after cardiac arrest
  • Persistent coma after return of spontaneous circulation (GCS motor score <6)
  • Requirement for intensive care management

Head Positioning Domain Eligibility:

  • Non-traumatic out-of-hospital or in-hospital cardiac arrest
  • Systolic blood pressure ≥80 mmHg or mean arterial pressure ≥65 mmHg (fluid resuscitation and vasopressor use permitted; transient hypotension recoverable within 20-30 minutes is acceptable)

Temperature Control Domain Eligibility:

  • Initial non-shockable cardiac arrest rhythm
  • Systolic blood pressure ≥80 mmHg or mean arterial pressure ≥65 mmHg (fluid resuscitation and vasopressor use permitted; transient hypotension recoverable within 20-30 minutes is acceptable)
  • Ability to initiate temperature control therapy within 240 minutes after return of spontaneous circulation

Exclusion Criteria:

Master Platform Exclusion:

  • Refusal of intensive care management
  • Extracorporeal cardiopulmonary resuscitation (ECPR)
  • Pregnancy or possible pregnancy
  • Cardiac arrest due to intracranial hemorrhage, subarachnoid hemorrhage, cerebral infarction, acute aortic dissection, or terminal cancer (including suspected cases)
  • Severe chronic obstructive pulmonary disease requiring home oxygen therapy
  • Poor pre-arrest neurological function (CPC 3-4) or poor overall functional status (OPC 3-4)
  • Pre-existing do-not-attempt-resuscitation (DNAR) order
  • Expected early death
  • Inability to obtain consent from a legally acceptable representative or the participant
  • Enrollment judged inappropriate by the investigator

Head Positioning Domain Exclusion:

  • Body temperature <30°C on hospital arrival
  • Refusal of consent for participation in the head positioning domain
  • Enrollment judged inappropriate by the investigator
  • Patients using Impella® (a percutaneous mechanical circulatory support catheter) at the time of ICU admission
  • Patients using an intra-aortic balloon pump (IABP) at the time of ICU admission
  • Patients for whom feedback-controlled device-based temperature management or fever prevention is not being performed and is not planned at the time of ICU admission

Temperature Control Domain Exclusion:

  • rCAST <4.5
  • rCAST ≥17.0
  • Traumatic cardiac arrest
  • Body temperature <30°C on hospital arrival
  • Refusal of consent for participation in the temperature control domain
  • Enrollment judged inappropriate by the investigator

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Head Positioning Strategy (near-supine vs head elevation)
Participants receive institutionally assigned post-cardiac arrest head positioning strategies according to the cluster-randomized crossover platform protocol, including head elevation (30°-45°) or near-supine positioning (0°-10°).
Процедура: Head Positioning
Institution-level assignment to predefined head positioning strategies during post-cardiac arrest intensive care management, including head elevation (30°-45°) or near-supine positioning (0°-10°).
Экспериментальный: Temperature Control Strategy (hypothermia vs normothermia)
Participants receive institutionally assigned post-cardiac arrest temperature control strategies according to the cluster-randomized crossover platform protocol, including targeted hypothermia (33-34°C) or normothermia/fever prevention strategies (36-37.5°C).
Другой: Temperature Control
Institution-level assignment to predefined temperature control strategies during post-cardiac arrest intensive care management, including targeted hypothermia (33-34°C) or normothermia/fever prevention strategies (36-37.5°C).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain
Временное ограничение: 90 days after hospital admission
Comparison of Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.
90 days after hospital admission
Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the temperature control domain
Временное ограничение: 90 days after hospital admission
Comparison of neurological outcomes between institutionally assigned temperature control strategies in adult patients with post-cardiac arrest syndrome and non-shockable initial rhythms.
90 days after hospital admission

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
mRS ≤3 on Day 30
Временное ограничение: 30 days after hospital admission
Comparison of neurological outcome (mRS ≤3) on Day 30 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.
30 days after hospital admission
mRS ≤3 on Day 30
Временное ограничение: 30 days after hospital admission
Comparison of neurological outcome (mRS ≤3) on Day 30 between institutionally assigned temperature control strategies in adult patients with post-cardiac arrest syndrome and non-shockable initial rhythms.
30 days after hospital admission
All-cause mortality on Day 30 and Day 90
Временное ограничение: 30 days and 90 days after hospital admission
Comparison of all-cause mortality on Day 30 and Day 90 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.
30 days and 90 days after hospital admission
All-cause mortality on Day 30 and Day 90
Временное ограничение: 30 days and 90 days after hospital admission
Comparison of all-cause mortality on Day 30 and Day 90 between institutionally assigned temperature control strategies in adult patients with post-cardiac arrest syndrome and non-shockable initial rhythms.
30 days and 90 days after hospital admission

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Kagawa University

Соавторы

Becton, Dickinson and Company

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

31 марта 2031 г.

Завершение исследования (Оцененный)

30 июня 2031 г.

Даты регистрации исследования

Первый отправленный

12 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

12 августа 2026 г.

Первый опубликованный (Действительный)

17 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • bpt-pcas

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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