[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kagawa University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100652064","breakthrough-platform-trial-for-pcas-100652064",false,"NCT07769086","Breakthrough Platform Trial for PCAS","Breakthrough Platform Trial for Post Cardiac Arrest Syndrome","BPT-PCAS","Inclusion Criteria:\n\nMaster Platform Eligibility:\n\n* Adult patients aged 18 years or older\n* Return of spontaneous circulation after cardiac arrest\n* Persistent coma after return of spontaneous circulation (GCS motor score \\\u003C6)\n* Requirement for intensive care management\n\nHead Positioning Domain Eligibility:\n\n* Non-traumatic out-of-hospital or in-hospital cardiac arrest\n* 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)\n\nTemperature Control Domain Eligibility:\n\n* Initial non-shockable cardiac arrest rhythm\n* 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)\n* Ability to initiate temperature control therapy within 240 minutes after return of spontaneous circulation\n\nExclusion Criteria:\n\nMaster Platform Exclusion:\n\n* Refusal of intensive care management\n* Extracorporeal cardiopulmonary resuscitation (ECPR)\n* Pregnancy or possible pregnancy\n* Cardiac arrest due to intracranial hemorrhage, subarachnoid hemorrhage, cerebral infarction, acute aortic dissection, or terminal cancer (including suspected cases)\n* Severe chronic obstructive pulmonary disease requiring home oxygen therapy\n* Poor pre-arrest neurological function (CPC 3-4) or poor overall functional status (OPC 3-4)\n* Pre-existing do-not-attempt-resuscitation (DNAR) order\n* Expected early death\n* Inability to obtain consent from a legally acceptable representative or the participant\n* Enrollment judged inappropriate by the investigator\n\nHead Positioning Domain Exclusion:\n\n* Body temperature \\\u003C30°C on hospital arrival\n* Refusal of consent for participation in the head positioning domain\n* Enrollment judged inappropriate by the investigator\n* Patients using Impella® (a percutaneous mechanical circulatory support catheter) at the time of ICU admission\n* Patients using an intra-aortic balloon pump (IABP) at the time of ICU admission\n* 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\n\nTemperature Control Domain Exclusion:\n\n* rCAST \\\u003C4.5\n* rCAST ≥17.0\n* Traumatic cardiac arrest\n* Body temperature \\\u003C30°C on hospital arrival\n* Refusal of consent for participation in the temperature control domain\n* Enrollment judged inappropriate by the investigator","ALL","18 Years",{"count":20,"type":21},630,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nThis 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.\n\nThe 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.\n\nParticipants 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.\n\nParticipants 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.",[27,28],"Cardiac Arrest (CA)","Post Cardiac Arrest Syndrome",[30,31,32,33],"platform trial","cluster randomized trial","head positioning","Temperature control","NOT_YET_RECRUITING","2026-08-12",{"date":37,"type":38},"2026-08-17","ACTUAL",{"date":40,"type":21},"2026-09-01",{"date":42,"type":21},"2031-06-30",{"name":44,"class":45},"Kagawa University","OTHER",12,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100575766","hypothermia-versus-normothermia-after-extracorporeal-cardiopulmonary-resuscitation-for-out-of-hospital-cardiac-arrest-100575766","NCT06776549","Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest","Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest: A Cluster Randomized Trial (SAVE-J NEUROTHERM Trial)","J-NEURO","Inclusion Criteria:\n\n* OHCA\n* Age of 18-75 years, known or estimated\n* An initial cardiac arrest rhythm of ventricular fibrillation\u002Fpulseless ventricular tachycardia or pulseless electrical activity\n\nExclusion Criteria:\n\n* ECMO initiated after sustained return of spontaneous circulation (ROSC) and patients with sustained ROSC before ECMO initiation\n* OHCA of presumed non-cardiac etiology\n* Time from emergency call or witnessed arrest to hospital arrival of \\>60 min\n* Time from hospital arrival to ECMO initiation of \\>60 min\n* Pre-hospital ECPR\n* Unavailability of the ECMO heat exchanger for temperature control\n* Glasgow Coma Scale score before temperature control of \\>8\n* Core body temperature upon hospital arrival of ≤32ºC\n* Surgical intervention before temperature control (e.g., surgical intervention for the primary disease or complications related to resuscitation\u002FECMO procedures)\n* Do Not Attempt Resuscitation) order confirmed prior to temperature control\n* Limitations in intensive care before temperature control\n* Known cerebral performance category (CPC) of 3-4 before cardiac arrest\n* Known chronic obstructive pulmonary disease with home oxygen therapy\n* Known or suspected pregnancy\n* Concomitant illness, such as malignancy, shortens life expectancy (180-day survival unlikely)\n* Consent not obtained or withdrawn by the participant or surrogate\n* Other reasons, physician's decision not to enroll the patient","75 Years",{"count":57,"type":21},468,[24],"The SAVE-J NEUROTHERM trial is a cluster randomized trial that evaluated and compared the mortality risk, neurological outcomes, and adverse events between patients who underwent hypothermia and those who underwent normothermia after extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest.",[61,62,63,28],"Out-of-hospital Cardiac Arrest (OHCA)","ECMO Treatment","Temperature",[65,66,67,33,68],"Cardiac arrest","Out-of-hospital cardiac arrest (OHCA)","Extracorporeal cardiopulmonary resuscitation (ECPR)","Post cardiac arrest syndrome (PCAS)","RECRUITING","2026-08-06",{"date":72,"type":38},"2026-08-07",{"date":74,"type":38},"2025-01-06",{"date":76,"type":21},"2030-01-31",{"name":44,"class":45},29,""]