Breakthrough Platform Trial for Post Cardiac Arrest Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 630
- 试验地点
- 12
- 主要终点
- Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain
研究概览
简要总结
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.
详细描述
BPT-PCAS (Breakthrough Platform Trial for Post-Cardiac Arrest Syndrome) is a multicenter platform trial designed to evaluate whether early 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.
Despite advances in resuscitation and intensive care medicine, prognosis after post-cardiac arrest syndrome (PCAS) remains poor, particularly because of hypoxic-ischemic brain injury and systemic circulatory dysfunction. Many aspects of post-resuscitation intensive care management, including positioning strategies and targeted temperature management, are widely used in clinical practice but remain supported by limited high-quality randomized evidence, particularly during the ultra-early post-ROSC period.
BPT-PCAS is designed as a pragmatic multicenter cluster-randomized crossover platform trial conducted in Japan. Participating hospitals are randomized at the institutional level to predefined treatment strategies for fixed study periods. Hospitals subsequently cross over to alternative treatment strategies every 6 months according to a predefined allocation schedule. Randomization occurs at the hospital level rather than the individual patient level in order to facilitate immediate implementation of time-sensitive post-cardiac arrest interventions during emergency care.
The platform uses a master protocol structure with shared eligibility criteria, infrastructure, data management systems, and follow-up procedures across multiple intervention domains. Adult patients with persistent coma after ROSC who require intensive care are screened for eligibility under the master protocol. Individual domains may apply additional domain-specific inclusion and exclusion criteria.
The current platform includes multiple intervention domains evaluating different post-cardiac arrest care strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the institutional post-cardiac arrest care interventions, participating hospitals and treating clinicians are not blinded to assigned treatment strategies. The study is conducted using an open-label cluster-randomized crossover design.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Head Positioning Strategy (near-supine vs head elevation)
Participants receive institutionally assigned post-cardiac arrest head positioning strategies according to the cluster-randomized crossover platform protocol, including head elevation (30°-45°) or near-supine positioning (0°-10°).
干预措施: Head Positioning (Procedure)
Temperature Control Strategy (hypothermia vs normothermia)
Participants receive institutionally assigned post-cardiac arrest temperature control strategies according to the cluster-randomized crossover platform protocol, including targeted hypothermia (33-34°C) or normothermia/fever prevention strategies (36-37.5°C).
干预措施: Temperature Control (Other)
结局指标
主要结局
Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain
时间窗: 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
时间窗: 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.
次要结局
- mRS ≤3 on Day 30(30 days after hospital admission)
- All-cause mortality on Day 30 and Day 90(30 days and 90 days after hospital admission)