Breakthrough Platform Trial for PCAS

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

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

Treatments tested in this trial

  • Head Positioning
  • Temperature Control

Treatment groups

630 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kagawa University

Lead sponsor

Becton, Dickinson and Company

Collaborator