[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583282":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":35,"responsibleParty":179,"collaborators":182,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":187,"sex":193,"minAge":194,"maxAge":12,"enrollmentInfo":195,"targetDuration":12,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","Patient will be listed for liver transplantation through standard allocation only.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"ExTra Option","EXPERIMENTAL","Patients will receive the option to receive a graft that was declined by all German Transplant Centers but meets predefined quality criteria during at least 4 hours of normothermic machine perfusion (ExTra-LT) or a liver via regular allocation - whichever occurs first.\n\nDeclined liver grafts will be allocated based on Eurotransplant's first-come-first-serve principle, with consideration for transport logistics and recipient eligibility. Only grafts meeting the following criteria will be considered: Macrovesicular steatosis \\\u003C60%, fibrosis grade ≤F3, no histopathologic evidence of cirrhosis, graft weight between 1-2.5 kg, no previous machine perfusion preservation.",[18],"Device: Quality Assessment with Normothermic Machine Perfusion (NMP)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Quality Assessment with Normothermic Machine Perfusion (NMP)","Quality assessment using NMP in the experimental arm is performed according to previously published viability criteria for initially declined liver grafts, which are mandatory for all participating study centers, with minor device-specific modifications. These criteria are based on the Birmingham criteria used in the VITTAL trial for viability assessment of DBD and DCD grafts with the OrganOx Metra device and are comparable to the Groningen criteria used with the LiverAssist and PerLife device, with the exception of biliary viability.\n\nThese criteria are: Lactate clearance \\\u003C 2.5 mmol\u002FL, And two or more of the following: Evidence of bile production, maintenance of a perfusate pH \\>7.30 (without correction for at least one hour), glucose metabolism (falling perfusate glucose value with consistent downward trend), maintenance of stable arterial and portal venous flows (OrganOx Metra: 150 and 500 mL\u002Fmin respectively), homogeneous perfusion with soft consistency of the parenchyma.",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Nathanael Raschzok, MD","CONTACT","+49 30 450 552 001","nathanael.raschzok@charite.de",{"name":32,"role":28,"phone":33,"phoneExt":12,"email":34},"Simon Moosburner, MD","+49 30 450 552 595","simon.moosburner@charite.de",[36,55,70,84,98,114,127,140,153,166],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University Medical Center Hamburg-Eppendorf","RECRUITING","Hamburg","Free and Hanseatic City of Hamburg","20251","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],9.99302,53.55073,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":53,"phoneExt":12,"email":54},"Jacqueline Jahnke-Triankowski","+49 40 7410 52401","j.jahnke-triankowski@uke.de",{"facility":56,"status":38,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University Hospital RWTH Aachen","Aachen","North Rhine-Westphalia","52074",{"type":45,"coordinates":61},[62,63],6.08342,50.77664,{"lat":63,"lon":62},[66],{"name":67,"role":28,"phone":68,"phoneExt":12,"email":69},"Nils Laurenz","+49 241 80 89500","nlaurenz@ukaachen.de",{"facility":71,"status":38,"city":72,"state":58,"zip":73,"country":42,"countryCode":43,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University Hospital Bonn","Bonn","53127",{"type":45,"coordinates":75},[76,77],7.09549,50.73438,{"lat":77,"lon":76},[80],{"name":81,"role":28,"phone":82,"phoneExt":12,"email":83},"Steffen Manekeller, MD","+49 228 287 15215","steffen.manekeller@ukbonn.de",{"facility":85,"status":38,"city":86,"state":58,"zip":87,"country":42,"countryCode":43,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University Hospital Muenster","Münster","49149",{"type":45,"coordinates":89},[90,91],7.62571,51.96236,{"lat":91,"lon":90},[94],{"name":95,"role":28,"phone":96,"phoneExt":12,"email":97},"Kerstin Kemmann","+49 251 83 56361","kerstin.kemmann@ukmuenster.de",{"facility":99,"status":38,"city":100,"state":101,"zip":102,"country":42,"countryCode":43,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin","Berlin","State of Berlin","13353",{"type":45,"coordinates":104},[105,106],13.41053,52.52437,{"lat":106,"lon":105},[109,112],{"name":27,"role":28,"phone":110,"phoneExt":12,"email":111},"+49 30 450 552001","extra-trial@charite.de",{"name":32,"role":113,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"facility":115,"status":38,"city":116,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Department of General, Visceral and Transplant Surgery, Hannover Medical School","Hanover",{"type":45,"coordinates":118},[119,120],9.73322,52.37052,{"lat":120,"lon":119},[123],{"name":124,"role":28,"phone":125,"phoneExt":12,"email":126},"Philipp Felgendreff, MD","+49 0511 532-6534\u002F6527","felgendreff.philipp@mh-hannover.de",{"facility":128,"status":38,"city":129,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Department of General, Visceral and Transplantation Surgery, LMU University Hospital, LMU Munich","München",{"type":45,"coordinates":131},[132,133],13.31243,51.60698,{"lat":133,"lon":132},[136],{"name":137,"role":28,"phone":138,"phoneExt":12,"email":139},"Michael Eder","+49 089 4400-76573","kcs@med.uni-muenchen.de",{"facility":141,"status":38,"city":142,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Department of Surgery, University Hospital Regensburg","Regensburg",{"type":45,"coordinates":144},[145,146],12.10161,49.01513,{"lat":146,"lon":145},[149],{"name":150,"role":28,"phone":151,"phoneExt":12,"email":152},"Stefan Brunner","+49 0941 944-6809","Stefan.Brunner@ukr.de",{"facility":154,"status":38,"city":155,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Eberhard Karls University of Tübingen, Department of General Visceral and Transplant Surgery","Tübingen",{"type":45,"coordinates":157},[158,159],9.05222,48.52266,{"lat":159,"lon":158},[162],{"name":163,"role":28,"phone":164,"phoneExt":12,"email":165},"Lisa Vogt","+49 07071 29-61681","Lisa.Vogt@med.uni-tuebingen.de",{"facility":167,"status":38,"city":168,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Department of General, Visceral, Transplantation, Vascular, and Pediatric Surgery, University Hospital Wurzburg","Würzburg",{"type":45,"coordinates":170},[171,172],9.95121,49.79391,{"lat":172,"lon":171},[175],{"name":176,"role":28,"phone":177,"phoneExt":12,"email":178},"Johann Lock","+49 931 201-0","Lock_J@ukw.de",{"type":113,"investigatorFullName":180,"investigatorTitle":181,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Nathanael Raschzok","Principal Investigator",[183],{"name":184,"class":6},"German Research Foundation","100583282","assessing-declined-liver-grafts-with-normothermic-machine-perfusion-to-reduce-transplant-waiting-time-100583282",false,"NCT06874296","Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time","Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation","ExTra","Inclusion Criteria:\n\n* Able to consent\n* ≥ 18 years old\n* Listed in status \"transplantable\" by the transplant conference of the study centre for liver transplantation, according to the guidelines of the German Medical Association valid at the time of inclusion\n* ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for \\[non\\]standard exceptions\n* Medically suitable and informed for transplantation with an organ that fulfils extended donor criteria (Eurotransplant ECD criteria)\n* Patient information and written consent to participate in the Extra trial\n* No participation in another interventional study during participation\n\nExclusion Criteria:\n\n* Listed for retransplantation\n* High-Urgency Listing\n* Listed for combined organ transplantation\n* Pregnancy","ALL","18 Years",{"count":196,"type":197},186,"ESTIMATED","INTERVENTIONAL",[200],"NA","The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. This process keeps a donated liver working outside the body before transplantation, allowing surgeons to assess whether livers previously considered unsuitable can still be used.\n\nThe main questions this study aims to answer are:\n\n* Does this method help patients get a transplant sooner?\n* Can this method make more livers available for transplant?\n* Does it improve survival and health after transplant?\n\nParticipants in this study must be on the waiting list for a liver transplant with a ReMELD-Na-Score of 21 or less (equivalent to MELD ≤25) and must not qualify for certain special exceptions. Participants will be randomly placed into one of two groups:\n\n* Experimental group: In addition to regular organ offers, these participants may receive a liver that was initially not considered for transplantation but meets quality standards after at least four hours of machine perfusion.\n* Control group: These participants will receive a liver through the usual transplant process.\n\nThe main measure of success is how quickly participants receive a transplant. Researchers will also look at other important factors, such as survival rates, quality of life, hospital stay, and complications after transplant.\n\nThis study may help improve liver transplantation by making better use of available donor livers, reducing waiting times, and improving patient outcomes.",[203,204,205],"Liver Transplantation","Liver Diseases","Surgery",[203,207,208,209],"Extended Criteria Donors","Normothermic Machine Perfusion","Discarded Liver Grafts","2026-04-14",{"date":212,"type":213},"2026-04-15","ACTUAL",{"date":215,"type":213},"2025-06-02",{"date":217,"type":197},"2030-12-31",{"name":5,"class":6},10]