Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Breakthrough Platform Trial for PCAS (BPT-PCAS)

12 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

630

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.

Coordonnées de l'étude

Lieux d'étude

  • Japon
    • Chiba
      • Chiba, Chiba, Japon, 2610012
        • Chiba Kaihin Municipal Hospital
        • Contact:
    • Fukuoka
      • Iizuka, Fukuoka, Japon, 8208505
    • Hiroshima
      • Hiroshima, Hiroshima, Japon, 7348551
        • Hiroshima University Hospital
        • Contact:
    • Hyōgo
      • Kobe, Hyōgo, Japon, 651-0073
        • Hyogo Emergency Medical Center
        • Contact:
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japon, 761-0701
    • Kyoto
      • Kyoto, Kyoto, Japon, 6158256
        • Kyoto Katsura Hospital
        • Contact:
    • Miyagi
      • Sendai, Miyagi, Japon, 9838520
        • National Hospital Organization Sendai Medical Center
        • Contact:
    • Okayama-ken
      • Okayama, Okayama-ken, Japon, 7008558
    • Saitama
      • Asaka, Saitama, Japon, 3510023
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japon, 113-8603
        • Nippon Medical School Hospital
        • Contact:
      • Musashino, Tokyo, Japon, 1800023
      • Sumida-ku, Tokyo, Japon, 1308575
        • Tokyo Metropolitan Bokutoh Hospital
        • Contact:

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

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 croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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°).
Procédure: 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°).
Expérimental: 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).
Autre: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
mRS ≤3 on Day 30
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

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

Parrainer

Kagawa University

Collaborateurs

Becton, Dickinson and Company

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 (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

31 mars 2031

Achèvement de l'étude (Estimé)

30 juin 2031

Dates d'inscription aux études

Première soumission

12 août 2026

Première soumission répondant aux critères de contrôle qualité

12 août 2026

Première publication (Réel)

17 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • bpt-pcas

Plan pour les données individuelles des participants (IPD)

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

INDÉCIS

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

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 .

S'abonner