[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589129":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":107,"collaborators":19,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":19,"enrollmentInfo":119,"targetDuration":19,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":136,"whyStopped":19,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Rennes University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Normothermic oxygenated perfusion (NMP) viability testing","EXPERIMENTAL","Discarded liver grafts are connected to a normothermic perfusion machine (OrganOx Metra®) for a period of 4 to 12 hours prior to transplantation, to assess their viability.",[13],"Other: NMP viability testing",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"NMP viability testing","NMP viability testing before transplantation of discarded livers",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Heithem JEDDOU, MD","CONTACT","+0033299289841","Heithem.JEDDOU@chu-rennes.fr",[27,44,57,70,81,94],{"facility":28,"status":19,"city":29,"state":19,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"APHP_Hôpital Beaujon","Clichy","92110","France","FR",{"type":34,"coordinates":35},"Point",[36,37],2.30952,48.90018,{"lat":37,"lon":36},[40,42],{"name":41,"role":23,"phone":19,"phoneExt":19,"email":19},"Mickael LESURTEL, MD",{"name":19,"role":23,"phone":19,"phoneExt":19,"email":43},"mickael.lesurtel@aphp.fr",{"facility":45,"status":19,"city":46,"state":19,"zip":47,"country":31,"countryCode":32,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Hôpital Croix Rousse","Lyon","69003",{"type":34,"coordinates":49},[50,51],4.84789,45.74906,{"lat":51,"lon":50},[54],{"name":55,"role":23,"phone":19,"phoneExt":19,"email":56},"Jean-Yves MABRUT, MD","jean-yves.mabrut@chu-lyon.fr",{"facility":58,"status":19,"city":59,"state":19,"zip":60,"country":31,"countryCode":32,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"CHU de Montpellier","Montpellier","34090",{"type":34,"coordinates":62},[63,64],3.87635,43.61093,{"lat":64,"lon":63},[67],{"name":68,"role":23,"phone":19,"phoneExt":19,"email":69},"Astrid HERRERO, MD","a-herrero@chu-montpellier.fr",{"facility":71,"status":19,"city":72,"state":19,"zip":73,"country":31,"countryCode":32,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"CHU de Rennes PONTCHAILLOU","Rennes","35000",{"type":34,"coordinates":75},[76,77],-1.67431,48.11109,{"lat":77,"lon":76},[80],{"name":22,"role":23,"phone":19,"phoneExt":19,"email":25},{"facility":82,"status":19,"city":83,"state":19,"zip":84,"country":31,"countryCode":32,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"CHRU Tours","Tours","37170",{"type":34,"coordinates":86},[87,88],0.70398,47.39484,{"lat":88,"lon":87},[91],{"name":92,"role":23,"phone":19,"phoneExt":19,"email":93},"Ephrem SALAME","ephrem.salame@chu-tours.fr",{"facility":95,"status":19,"city":96,"state":19,"zip":97,"country":31,"countryCode":32,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"APHP_Hopital Paul Brousse","Villejuif","94800",{"type":34,"coordinates":99},[100,101],2.35992,48.7939,{"lat":101,"lon":100},[104],{"name":105,"role":23,"phone":19,"phoneExt":19,"email":106},"Marc Antoine ALLARD, MD","marcantoine.allard@aphp.fr",{"type":108,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100589129","phase-2-normothermic-oxygenated-perfusion-nmp-viability-testing-before-transplantation-of-discarded-livers-100589129",false,"NCT06950398","Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers","Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers. An Open Label, Non-randomized, Prospective, Single Arm Trial","TRANSPERF","INCLUSION CRITERIA :\n\nFOR LIVER DONORS\n\n* Donation after brainstem death (DBD)\n* Liver graft refused by 5 different transplant centres and after rescue allocation (\"hors tour\")\n\nFOR LIVER TRANSPLANT RECIPIENTS\n\n* ≥ 18 years old\n* Candidates for a first elective liver transplantation (patients with a pre-transplant work-up excluding: re-transplantation, emergency transplantation (e.g. fulminant hepatitis), multi-organ or heterotopic transplantation)\n* UNOS status IV (non-ventilated, no vasopressor support)\n* Absence of renal insufficiency defined as a GFR of less than 60 mL\u002Fmin\u002F1.73 m² for three months or more\n* MELD Score ≤ 25\n* Willing and able to attend follow-up examinations\n* Having signed an informed consent document\n\nNON-INCLUSION CRITERIA:\n\nFOR LIVER DONORS\n\n* Macroscopic features of advanced fibrosis or cirrhosis at procurement\n* Transplantation using a split graft, in situ or ex situ\n* Estimated cold ischemic time greater than 8 hours (5 hours maximum of graft transport in cold ischemia)\n\nFOR LIVER TRANSPLANT RECIPIENTS\n\n* Mentally or legally incapacitated\n* Transplantation for fulminant hepatic failure\n* Early or late re-transplantation\n* Combined liver transplant with any other organ, en-bloc or not\n* Heterotopic liver transplantation","ALL","18 Years",{"count":120,"type":121},99,"ESTIMATED","INTERVENTIONAL",[124],"PHASE2","Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in France, 12.9% of patients on the waitlist either died or were delisted for worsening of their condition.\n\nHowever a substantial number of perfectly viable organs are wrongly discarded based on a highly subjective assessment as the level of acceptance varies widely depending on the physician's judgement.\n\nThe idea of using Normothermic Machine Perfusion (NMP) not only to preserve the liver graft but also for selection purposes is a concept that has been already investigated. A few trials have analyzed the value of normothermic perfusion to assess rejected liver grafts.\n\nSeveral teams demonstrated that NMP provides a tool to assess organ viability pre-transplantation as the liver is able to maintain an almost physiological metabolism.\n\nThese preliminary results came from small samples, 45% of which originated from donation after circulatory death (DCD). They need confirmation in a larger sample of organs from donors with brainstem death (DBD), adapted to the French liver allocation system.\n\nThis trial will reproduce and confirm the results of the previous studies in order to establish viability testing as the de facto method for high-risk or rejected grafts. It will also validate existing viability markers so as to define a new standard for viability testing using NMP.",[127,128,129],"Organ Transplantation","Liver Dysfunction","Liver Diseases",[131,132,133,134,135],"Liver Transplantation","Normothermic oxygenated perfusion","NMP","Discarded livers","Viability assessment","NOT_YET_RECRUITING","2025-08-14",{"date":139,"type":140},"2025-08-15","ACTUAL",{"date":142,"type":121},"2025-12-15",{"date":144,"type":121},"2029-06-15",{"name":5,"class":6},6]