[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524762":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":135,"collaborators":18,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":18,"enrollmentInfo":148,"targetDuration":18,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Treatment group will receive extracorporeal photopheresis. First, a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.",[13],"Procedure: Extracorporeal Photopheresis",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Control group will be observed and no active treatment will be administered. This is our standard of care in the studied clinical situation.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Extracorporeal Photopheresis","Patients randomized into the interventional group will receive ECP. ECP will be started within one week after randomization. Initially a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.",[9],[26],{"name":27,"affiliation":5,"role":28},"Alberto Benazzo, MD PhD","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Caroline Hillebrand, MD","CONTACT","+4314040069470","+436641107970","caroline.hillebrand@outlook.com",{"name":27,"role":32,"phone":37,"phoneExt":18,"email":38},"+4314040052600","alberto.benazzo@meduniwien.ac.at",[40,56,70,83,96,109,122],{"facility":5,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Vienna","1090","Austria","AT",{"type":47,"coordinates":48},"Point",[49,50],16.37208,48.20849,{"lat":50,"lon":49},[53,55],{"name":27,"role":32,"phone":54,"phoneExt":18,"email":38},"00436766093043",{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":57,"status":58,"city":59,"state":18,"zip":18,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"UZ Leuven","NOT_YET_RECRUITING","Leuven","Belgium","BE",{"type":47,"coordinates":63},[64,65],4.70093,50.87959,{"lat":65,"lon":64},[68],{"name":69,"role":32,"phone":18,"phoneExt":18,"email":18},"Robin Vos",{"facility":71,"status":58,"city":72,"state":18,"zip":18,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University Hospital Center Zagreb","Zagreb","Croatia","HR",{"type":47,"coordinates":76},[77,78],15.97798,45.81444,{"lat":78,"lon":77},[81],{"name":82,"role":32,"phone":18,"phoneExt":18,"email":18},"Feđa Džubur",{"facility":84,"status":58,"city":85,"state":18,"zip":18,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Copenhagen University Hospital, Rigshospitalet","Copenhagen","Denmark","DK",{"type":47,"coordinates":89},[90,91],12.56553,55.67594,{"lat":91,"lon":90},[94],{"name":95,"role":32,"phone":18,"phoneExt":18,"email":18},"Michael Perch",{"facility":97,"status":58,"city":98,"state":18,"zip":18,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Hôpital Foch","Suresnes","France","FR",{"type":47,"coordinates":102},[103,104],2.22929,48.87143,{"lat":104,"lon":103},[107],{"name":108,"role":32,"phone":18,"phoneExt":18,"email":18},"Jonathan Messika",{"facility":110,"status":58,"city":111,"state":18,"zip":18,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Policlinico San Matteo Pavia Fondazione IRCCS","Pavia","Italy","IT",{"type":47,"coordinates":115},[116,117],9.15917,45.19205,{"lat":117,"lon":116},[120],{"name":121,"role":32,"phone":18,"phoneExt":18,"email":18},"Federica Meloni",{"facility":123,"status":58,"city":124,"state":18,"zip":18,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"University Medical Centre Ljubljana","Ljubljana","Slovenia","SI",{"type":47,"coordinates":128},[129,130],14.50513,46.05108,{"lat":130,"lon":129},[133],{"name":134,"role":32,"phone":18,"phoneExt":18,"email":18},"Matevž Harlander",{"type":28,"investigatorFullName":136,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Alberto Benazzo","Priv. Doz. Dr. Alberto Benazzo, PhD","100524762","a-prospective-randomized-trial-of-ecp-in-subclinical-amr-100524762",false,"NCT06112951","A Prospective Randomized Trial of ECP in Subclinical AMR","The Use of Extracorporeal Photopheresis as Immunomodulatory Therapy of Subclinical Antibody-mediated Rejection After Lung Transplantation: a Prospective RCT","EUROEXPORT-DSA","Inclusion Criteria:\n\n* Bilateral lung transplantation\n* dnDSAs \\> 3 months with a MFI \\> 1000\n* No signs of allograft dysfunction\n* Alemtuzumab induction therapy\n\nExclusion Criteria:\n\n* Inclusion in other studies\n* Retransplantation\n* Multi-organ transplantation\n* \\> 12 months after transplantation","ALL","18 Years",{"count":149,"type":150},80,"ESTIMATED","INTERVENTIONAL",[153],"NA","The goal of this clinical trial is to evaluate the therapeutic effect of extracorporeal photopheresis in subclinical antibody-mediated rejection after lung transplantation.The main questions it aims to answer are:\n\n1. Does ECP therapy result in a significant reduction in MFI (Mean Fluorescence Intensity) from the baseline MFI in clinically stable patients with persistent (\\>6 months) dnDSAs (MFI\\>1000)?\n2. What is the impact of ECP therapy on the following outcomes in these patients: ACR, clinical AMR, CLAD, infections, drop-out rate, survival, adverse events?\n\nParticipants will be randomized into two groups. Each group will include 40 patients. The control group will be observed and no active treatment will be administered. The treatment group will receive extracorporeal photopheresis. First, a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.\n\nResearchers will compare the two groups regarding: MFI value, development of ACR, clinical AMR, CLAD, infections, survival, adverse events, immunophenotyping, miRNA expression profiling, cytokine expression, gene expression signature of PBMCs and proteomic characterization.",[156,157],"Antibody-mediated Rejection","Lung Transplant Rejection","2024-07-08",{"date":160,"type":161},"2024-07-09","ACTUAL",{"date":163,"type":161},"2024-03-01",{"date":165,"type":150},"2027-06-01",{"name":5,"class":6},7]