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Breakthrough Platform Trial for PCAS

ConditionsCardiac Arrest (CA)Post Cardiac Arrest Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKagawa University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Head Positioning

    Procedure/Surgery

    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

    Other intervention

    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).

Treatment groups

630 Participants
are divided into 2 treatment groups
Group A: Head Positioning Strategy (near-supine vs head elevation)Experimental treatment 1 intervention
Group B: Temperature Control Strategy (hypothermia vs normothermia)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
90 days after hospital admission
2

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

Comparison of neurological outcomes between institutionally assigned temperature control strategies in adult patients with post-cardiac arrest syndrome and non-shockable initial rhythms.

Time frame
90 days after hospital admission

Secondary outcomes

1

mRS ≤3 on Day 30

Comparison of neurological outcome (mRS ≤3) on Day 30 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.

Time frame
30 days after hospital admission
2

mRS ≤3 on Day 30

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.

Time frame
30 days after hospital admission
3

All-cause mortality on Day 30 and Day 90

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.

Time frame
30 days and 90 days after hospital admission
4

All-cause mortality on Day 30 and Day 90

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.

Time frame
30 days and 90 days after hospital admission

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kagawa University

Lead sponsor

Becton, Dickinson and Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: