Breakthrough Platform Trial for PCAS

NCT07769086 · tracked via the Priya Life Science Japan tracker

Sponsor

Kagawa University

Phase

Not applicable

Started

2026-09-01

Last updated

2026-08-17

Condition(s) studied

Cardiac Arrest (CA)Post Cardiac Arrest Syndrome

Investigational drug(s) / intervention(s)

Head PositioningTemperature Control

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°).

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).

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain — 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.
Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the temperature control domain — 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.

Trial sites (12)

Facility	City	Region
Chiba Kaihin Municipal Hospital	Chiba	Chiba
Aso Iizuka Hospital	Iizuka	Fukuoka
Hiroshima University Hospital	Hiroshima	Hiroshima
Hyogo Emergency Medical Center	Kobe	Hyōgo
Kagawa University Hospital	Kita-gun	Kagawa-ken
Kyoto Katsura Hospital	Kyoto	Kyoto
National Hospital Organization Sendai Medical Center	Sendai	Miyagi
Okayama University Hospital	Okayama	Okayama-ken
TMG Asaka Medical Center	Asaka	Saitama
Nippon medical school hospital	Bunkyō-Ku	Tokyo
Musashino Red Cross Hospital	Musashino	Tokyo
Tokyo Metropolitan Bokutoh Hospital	Sumida-ku	Tokyo

More Kagawa University trials in Japan

Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest Recruiting

Other trials for the same condition

Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07769086 on ClinicalTrials.gov ↗ ← All trials in Japan