[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623165":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":54,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":18,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":82,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemoadsorption","EXPERIMENTAL","Cardiopulmonary bypass (CPB) will be conducted as per institutional protocols and an HA-60® cartridge (Jafron Biomedical, Guangdong, China) will be inserted within the circuit for hemoadsorption.",[13],"Device: Hemoadsorption",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care)",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","The hemoadsorption treatment will be performed during the entire duration of the CPB. The blood flow within the hemoadsorber will be controlled and set to 7% of the theoretical minimal CPB flow which is calculated as 2.5 L\u002Fmin\u002F1.73m2 of body surface area.",[9],[25],{"name":26,"affiliation":27,"role":28},"Antoine Schneider, MD-PhD","Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Isabelle Cristiani","CONTACT","+41 79 556 84 60","isabelle.cristiani@chuv.ch",{"name":26,"role":32,"phone":18,"phoneExt":18,"email":36},"antoine.schneider@chuv.ch",[38],{"facility":39,"status":18,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Centre Hospitalier Universitaire Vaudois (CHUV)","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":46,"coordinates":47},"Point",[48,49],6.63282,46.516,{"lat":49,"lon":48},[52],{"name":26,"role":32,"phone":53,"phoneExt":18,"email":36},"+41 79 556 68 72",{"type":28,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Antoine Schneider","Principal Investigator","100623165","jafron-cytokine-adsorber-during-pediatric-open-heart-surgeries-100623165",false,"NCT07393087","Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries","JACKPOT","Inclusion Criteria:\n\n* Children ≤ 10 years old at study inclusion\n* Children weighing at least 5 kg at study inclusion\n* Planned for open-heart cardiac surgery with CPB-time ≥ 120 min and aortic clamping.\n* Informed consent obtained from parent(s)\u002Flegal representative\n\nExclusion Criteria:\n\n* Children having an indication to receive hemoadsorption during CPB for drugs removal or other medically justified reason\n* Previous enrolment into the current study\n* Off-pump procedure\n* Chronic immunosuppression (chronic corticosteroid therapy, chemotherapy, anti-leucocyte drugs, TNF blockers or else)\n* Known allergy to heparin or heparin induced thrombocytopenia.\n* Severe thrombopenia (platelets count before surgery \\\u003C 20G\u002FL)\n* Parent(s)\u002Flegal representative not able to understand\u002Fread French and\u002For English\n* Participation in another conflicting research study","ALL","10 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"NA","This prospective single-center randomized controlled trial aims at evaluating the safety and feasibility of an hemoadsorption protocol using Jafron HA-60 during cardio-pulmonary bypass in 20 pediatric patients undergoing open-heart surgery.",[74,75,76,77,78],"Cardiac Surgery Recovery","Inflammation","Complex Cardiovascular Surgery With Cardiopulmonary Bypass","Cytokine Storm","Pediatric Open Heart Surgery",[80,81,9],"Feasibility pilot study","Pediatric open heart surgery","NOT_YET_RECRUITING","2026-02-06",{"date":85,"type":86},"2026-02-10","ACTUAL",{"date":88,"type":68},"2026-03",{"date":90,"type":68},"2029-04",{"name":5,"class":6},1]