[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652276":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":12,"responsibleParty":35,"collaborators":12,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":12,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":12,"overallStatus":62,"whyStopped":12,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":12},{"fullName":5,"class":6},"Institut Jantung Negara","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","NO_INTERVENTION","Participants undergoing cardiac surgery with cardiopulmonary bypass and expected prolonged bypass duration (\\>180 minutes) will receive standard intraoperative management according to institutional practice versus hemoadsorption device and standard of care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Hemoadsorption Group","EXPERIMENTAL","Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition to standard-of-care versus standard of care, integrated into the cardiopulmonary bypass (CPB) circuit during surgery. The specific cartridge is chosen based on the patient's weight. The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine. This treatment starts at the beginning of the bypass and ends when the bypass is completed.",[18],"Device: Hemoadsorption (Jafron HA-60\u002FHA380)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Hemoadsorption (Jafron HA-60\u002FHA380)","Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition standard of care integrated into the cardiopulmonary bypass (CPB) circuit during surgery. The specific cartridge is chosen based on the patient's weight. The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine. This treatment starts at the beginning of the bypass and ends when the bypass is completed.",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Sivakumar Sivalingam","CONTACT","+6032617 8200","sivakumar@ijn.com.my",{"name":32,"role":28,"phone":33,"phoneExt":12,"email":34},"Irni Yusnida Md Rashid","+6032617 8385","irni@ijn.com.my",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Norfaniza Zabidi","Study Coordinator","100652276","localized-evidence-of-cytokine-adsorption-therapy-during-pediatric-cardiac-surgery-a-single-center-randomized-controlled-trial-leat-100652276",false,"NCT07771491","Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)","LEAT","Inclusion Criteria:\n\n* Children (\\\u003C18 years old at study inclusion)\n* Undergoing a cardiac surgery with CPB of expected duration \\> 180min\n* Prophylactic application of HA during CPB for suspected SIRS.\n\nExclusion Criteria:\n\n* Non-ability to gather informed consent from parents or legal representative. Enrolled in conflicting research study\n* Off-pump procedure\n* Non-steroidal anti-inflammatory treatment in the previous 7 days Pregnancy","ALL","0 Years","17 Years",{"count":50,"type":51},120,"ESTIMATED","INTERVENTIONAL",[54],"NA","The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients undergoing major heart surgery.\n\nObjective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine.\n\nStudy Population All children \\\u003C 18 years of age at the time of enrollment who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass (CPB) with an expected duration of \\>180 minutes.\n\nMethodology This single-center study will randomly assign patients before surgery into 2 groups: 1 group will receive hemoadsorption treatment plus with standard-of-care (intervention group), while the other group will receive standard-of-care (control group) only.\n\nPrimary Endpoint:\n\nTo evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.\n\nSecondary Endpoints:\n\n1. Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours\n2. PELOD-2 score on ICU admission, at 48 hours post ICU admission\n3. ICU and hospital length of stay\n4. ICU, hospital, and 28 days mortality\n5. Mechanical - ventilation (MV) free days at day\n6. Renal replacement therapy (RRT) free days at day 28\n7. Vasopressors free days at day 28\n8. Acute kidney injury\n9. Bleeding complications\n10. Post operative liver injury\n\nData Collection:\n\nBlood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure .\n\nDuration: The study is expected to last 24 months.",[57,58,59,60,61],"Congenital Heart Disease","Open Heart Surgery","Cardiopulmonary Bypass","Endocarditis Acute and Subacute","Cyanotic Heart Disease","NOT_YET_RECRUITING","2026-08-13",{"date":65,"type":66},"2026-08-18","ACTUAL",{"date":68,"type":51},"2026-10-01",{"date":70,"type":51},"2028-10-31",{"name":37,"class":6}]