[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556863":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":42,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":42,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":42,"enrollmentInfo":73,"targetDuration":42,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":42,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hospital San Carlos, Madrid","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Buckberg","ACTIVE_COMPARATOR","Patients who will be administered Buckberg blood cardioplegia.",[13],"Drug: Buckberg Cardi-Braun",{"label":15,"type":16,"description":17,"interventionNames":18},"Custodiol","EXPERIMENTAL","Patients who will be administered Custodiol crystalloid cardioplegia.",[19],"Drug: Custodiol Htk Soln",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Custodiol Htk Soln","Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.",[15],[27],"Custodiol HTK solution. ACT: K944866",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Buckberg Cardi-Braun","Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.",[9],[33],"Buckberg Cardi-Braun cardioplegia solution. ATC: B05X A16.",[35],{"name":36,"affiliation":5,"role":37},"Lourdes Montero Cruces","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","913303000",null,"lourdes.montero@salud.madrid.org",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hospital Clínico San Carlos","RECRUITING","Madrid","28040","Spain","ES",{"type":53,"coordinates":54},"Point",[55,56],-3.70256,40.4165,{"lat":56,"lon":55},[59],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":60},"l.monterocr@gmail.com",{"type":62,"investigatorFullName":36,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Principal Investigator","100556863","phase-4-evaluation-of-clinical-impact-of-the-type-of-cardioplegia-used-in-the-patient-undergoing-major-cardiac-surgery-100556863",false,"NCT06530641","Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.","Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery with Extracorporeal Circulation. CARDIO-HEART Clinical Trial.","Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Aortic arch procedures.\n3. Procedures in which hypothermia \\\u003C28ºC is expected during the intervention.\n4. Minimally invasive procedures \"Port Access\".\n5. Active endocarditis.\n6. Emerging procedures.\n7. Isolated aortic valve replacements.\n8. Decision of the main surgeon not to participate in the study due to other clinical criteria.","ALL","18 Years",{"count":74,"type":75},600,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.",[81,82,83],"Cardiac Surgery","Cardioplegia","Heart Arrest","2025-03-13",{"date":86,"type":87},"2025-03-17","ACTUAL",{"date":89,"type":87},"2024-12-01",{"date":91,"type":75},"2026-12",{"name":36,"class":6},1]