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
Sponsors and collaborators
Kagawa University
Lead sponsor
Becton, Dickinson and Company
Collaborator