[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518565":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":48,"responsibleParty":99,"collaborators":52,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":52,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":52,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":52,"overallStatus":50,"whyStopped":52,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Dr. F. Köhler Chemie GmbH","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Custodiol-N","EXPERIMENTAL","organ will be perfused with Custodiol-N solution",[13],"Drug: Custodiol-N",{"label":15,"type":16,"description":17,"interventionNames":18},"Custodiol","ACTIVE_COMPARATOR","organ will be perfused with Custodiol solution",[19],"Drug: Custodiol",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","heart will preserved in and will be treated with Custodiol-N solution",[9],[26],"Solution for organ preservation in transplantation",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"heart will preserved in and will be treated with Custodiol solution",[15],[26],[32],{"name":33,"affiliation":34,"role":35},"Christoph Knosalla, Prof. Dr.","Deutsches Herzzentrum der Charité","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Roman Petrov, Dr.","CONTACT","+ 49-6251-1083","-0","r.petrov@koehler-chemie.de",{"name":44,"role":39,"phone":45,"phoneExt":46,"email":47},"Kathleen Steyrer","+49-6221-56","36411","kathleen.steyrer@med.uni-heidelberg.de",[49,69,83],{"facility":34,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Berlin",null,"13353","Germany","DE",{"type":57,"coordinates":58},"Point",[59,60],13.41053,52.52437,{"lat":60,"lon":59},[63,66],{"name":33,"role":39,"phone":64,"phoneExt":52,"email":65},"+49 30 4593-2102","christoph.knosalla@dhzc-charite.de",{"name":67,"role":39,"phone":52,"phoneExt":52,"email":68},"Joachim Photiadis, Prof. Dr.","joachim.photiadis@dhzc-charite.de",{"facility":70,"status":50,"city":71,"state":52,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie","Giessen","35385",{"type":57,"coordinates":74},[75,76],8.67554,50.58727,{"lat":76,"lon":75},[79],{"name":80,"role":39,"phone":81,"phoneExt":52,"email":82},"Mohamed Salem, Dr. med.","+49 641 985-56314","Mohamed.Salem@chiru.med.uni-giessen.de",{"facility":84,"status":50,"city":85,"state":52,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik","München","81377",{"type":57,"coordinates":88},[89,90],13.31243,51.60698,{"lat":90,"lon":89},[93,96],{"name":94,"role":39,"phone":52,"phoneExt":52,"email":95},"Christine-Elena Kamla, Dr. med.","Christine.Kamla@med.uni-muenchen.de",{"name":97,"role":39,"phone":52,"phoneExt":52,"email":98},"Sebastian Michel, Dr. med.","sebastian.michel@med.uni-muenchen.de",{"type":100,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100518565","phase-2-study-of-organ-perfusion-in-heart-transplantation-in-children-100518565",false,"NCT06032195","Study of Organ Perfusion in Heart Transplantation in Children","A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children","Inclusion Criteria:\n\n* Age from birth to less than18 years\n* Recipients awaiting their first transplant\n* Ability of the patients and\u002F or their legal guardians to understand character and individual consequences of the clinical trial\n* written informed consent of the patients and\u002F or their legal guardians (must be available before enrolment in the study)\n* Patient listed on the waiting list for heart transplantation\n\nExclusion Criteria:\n\n* Patients who have participated within 30 days or are still participating in any other interventional studies\n* history of severe organic disease other than concerning the heart\n* history\u002Fdemonstration of HIV antibodies or AIDS\n* multiorgan transplantation\n* machine-perfused organ\n* the explantation team is affiliated to another clinic than transplantation team\n* Failing Fontan patients\n* Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities\n* Pregnancy and lactation","ALL","24 Hours","17 Years",{"count":112,"type":113},15,"ESTIMATED","INTERVENTIONAL",[116],"PHASE2","The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to \\\u003C18 years) being listed on the waiting list for heart transplantation. The main question it aims to answer is:\n\nto compare the safety of Custodiol-N in heart transplantation in children in comparison to its precursor product Custodiol.\n\nParticipants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.",[119],"Heart Transplantation","2026-01-28",{"date":122,"type":123},"2026-01-30","ACTUAL",{"date":125,"type":123},"2023-08-15",{"date":127,"type":113},"2027-09",{"name":5,"class":6},3]