Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Breakthrough Platform Trial for PCAS (BPT-PCAS)

12 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

630

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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°).
Procedur: 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°).
Experimentell: 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).
Övrig: 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
mRS ≤3 on Day 30
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kagawa University

Samarbetspartners

Becton, Dickinson and Company

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

31 mars 2031

Avslutad studie (Beräknad)

30 juni 2031

Studieregistreringsdatum

Först inskickad

12 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

12 augusti 2026

Första postat (Faktisk)

17 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • bpt-pcas

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera