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Breakthrough Platform Trial for PCAS

Not Yet RecruitingNA

Sponsor: Kagawa University

Conditions: Cardiac Arrest (CA), Post Cardiac Arrest Syndrome

Interventions: Head Positioning, Temperature Control

Countries: Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (12)

Chiba, Chiba, Japan
Iizuka, Fukuoka, Japan
Hiroshima, Hiroshima, Japan
Kobe, Hyōgo, Japan
Kita-gun, Kagawa-ken, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Okayama, Okayama-ken, Japan
Asaka, Saitama, Japan
Bunkyō-Ku, Tokyo, Japan
Musashino, Tokyo, Japan
Sumida-ku, Tokyo, Japan