[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-allograft-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-allograft-dysfunction":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645692","avoiding-recooling-after-normothermic-machine-perfusion-in-liver-transplantation-100645692",false,"NCT07692490","Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation","Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation: a Multicenter, Parallel-group, Open-label, Non-inferiority Randomized Controlled Trial","ARANMP-LT","Inclusion Criteria:\n\n* Age ≥18 years.\n* Listed for primary liver transplantation at the participating institution.\n* Assigned a liver graft preserved with normothermic machine perfusion or sequential hypothermic- normothermic machine perfusion (SHNMP).\n* Signed and dated informed consent prior study inclusion.\n\nExclusion Criteria:\n\n* Pediatric patients (age \\\u003C 18 years)\n* Patients undergoing re-transplantation (history of previous liver transplantation)\n* Patients with acute liver failure\n* Patients undergoing multi-organ transplantation (e.g., liver-kidney, liver-heart)\n* Temporarily unconscious patients\n* Patients unable to freely express consent.","ALL","18 Years",{"count":20,"type":21},170,"ESTIMATED","INTERVENTIONAL",[24],"NA","The ARANMP-LT study is a multicenter, open-label, randomized, parallel-group, non-inferiority clinical trial designed to evaluate whether avoiding graft recooling after normothermic machine perfusion (NMP) improves early outcomes following liver transplantation. Although graft recooling before implantation is common practice, experimental and preliminary clinical evidence suggests that abrupt temperature changes may contribute to ischemia-reperfusion injury.\n\nAdult recipients of deceased-donor liver grafts preserved with NMP or sequential hypothermic-normothermic machine perfusion (SHNMP) will be randomized in a 1:1 ratio to either standard graft implantation with recooling using cold preservation solution (control group) or implantation without recooling using a room-temperature 5% albumin flush immediately before reperfusion (intervention group).\n\nThe primary objective is to compare the incidence of Early Allograft Dysfunction (EAD), defined according to the Olthoff criteria, between the two treatment groups. Secondary objectives include evaluation of histopathological ischemia-reperfusion injury using the Suzuki score, vascular and biliary complications, primary non-function, post-reperfusion syndrome, patient and graft survival, length of intensive care unit and hospital stay, perioperative transfusion requirements, and safety outcomes. A total of 170 participants will be enrolled across multiple Italian liver transplant centers and followed for 90 days after transplantation.",[27,28,29],"Liver Transplantation (LT)","Ischemia-Reperfusion Injury","Early Allograft Dysfunction",[31,32,28,29,33,34],"Liver Transplantation","Normothermic Machine Perfusion","Organ Preservation","Liver Graft","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-14","ACTUAL",{"date":41,"type":21},"2026-07-07",{"date":43,"type":21},"2028-10-06",{"name":45,"class":46},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies","OTHER",14,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100641359","intraoperative-assessment-of-microcirculatory-function-using-vascular-occlusion-test-during-liver-transplantation-100641359","NCT07658794","Intraoperative Assessment of Microcirculatory Function Using Vascular Occlusion Test During Liver Transplantation","The Predictive Value of the Vascular Occlusion Test During Orthotopic Liver Transplantation for the Development of Early Allograft Dysfunction","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Patients scheduled to undergo orthotopic liver transplantation\n* Ability to obtain intraoperative Near-Infrared Spectroscopy measurements\n* Written informed consent obtained before enrollment\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Refusal or inability to provide informed consent\n* Emergency liver transplantation without sufficient time for enrollment\n* Inability to perform the Vascular Occlusion Test or obtain reliable NIRS measurements\n* Severe peripheral vascular disease or local upper-limb conditions interfering with monitoring",{"count":56,"type":21},50,"30 Days","OBSERVATIONAL","Early allograft dysfunction (EAD) remains one of the most important complications following orthotopic liver transplantation (OLT). Currently, there is no established intraoperative biomarker that reliably predicts graft dysfunction at an early stage. Near-infrared spectroscopy (NIRS) combined with the vascular occlusion test (VOT) is a non-invasive method for assessing tissue oxygenation and microcirculatory reserve. This prospective observational study aims to investigate whether VOT-derived parameters, including desaturation slope, recovery slope and post-ischemic hyperemic area under the curve (AUC-H), can predict EAD in liver transplant recipients. Measurements will be performed at four predefined intraoperative timepoints: after induction of anesthesia, during the anhepatic phase, during the neohepatic phase and at the end of surgery. The primary outcome is the occurrence of EAD according to Olthoff criteria.",[61,29],"Liver Cirrhosis",[63,64,29,31,65],"Vascular Occlusion Test","Near-Infrared Spectroscopy","Microcirculation","NOT_YET_RECRUITING","2026-06-27",{"date":69,"type":39},"2026-07-01",{"date":71,"type":21},"2026-06",{"date":73,"type":21},"2027-06",{"name":75,"class":46},"Ippokrateio General Hospital of Thessaloniki",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":5},"100644712","new-biomarkers-for-organ-viability-assessment-during-hypothermic-machine-perfusion-in-liver-transplantation-the-role-of-extemporaneous-histological-examination-100644712","NCT07674394","New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.","LOVE","Inclusion Criteria:\n\n1. Adult liver transplant recipients (≥18 years of age).\n2. Donor liver grafts from either Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD).\n3. Grafts undergoing hypothermic oxygenated perfusion (HOPE) (HOPE or D-HOPE) for a minimum duration of 1 hour prior to transplantation.\n4. Availability of two wedge liver biopsy samples: one pre perfusion and one post-perfusion.\n5. Grafts preserved using standard cold storage protocols and transported in ice-cold Servator C™ solution.\n6. Informed consent obtained from the recipient (or legal representative, where applicable) for the use of clinical and histological data for research purposes.\n\nExclusion Criteria:\n\n1. Inadequate or fragmented biopsy samples, preventing proper histological evaluation.\n2. Biopsy samples showing histological features of pre-existing chronic liver disease (e.g., cirrhosis, autoimmune hepatitis, chronic viral hepatitis).\n3. Liver grafts subjected to normothermic perfusion or other non hypothermic perfusion techniques.\n4. Organs undergoing experimental or non-standard perfusion protocols.\n5. Grafts from donors \\\u003C18 years of age.\n6. Recipient refusal or inability to provide informed consent.\n7. Technical failure during perfusion (e.g., incomplete perfusion due to device malfunction or vascular anomalies).\n8. Known malignancy in the donor with potential liver involvement, excluding donors with small incidentalomas as per standard guidelines.",{"count":85,"type":21},150,[24],"Liver transplantation is a life-saving treatment for patients with severe liver disease. Because of the shortage of donor organs, transplant centers increasingly use donor livers that may be more vulnerable to injury and dysfunction. To improve the quality of these organs before transplantation, many centers use hypothermic oxygenated machine perfusion (HOPE or D-HOPE), a technique that preserves the liver under cold, oxygenated conditions. However, there are currently no widely accepted methods to determine whether a liver is functioning well enough during this preservation process.\n\nThe purpose of this study is to investigate whether changes observed in liver tissue during hypothermic machine perfusion can help predict how well the transplanted liver will function after surgery. The study will compare liver biopsy samples collected before and after one hour of perfusion and will analyze biological markers released into the perfusion fluid, including markers of mitochondrial injury and inflammation.\n\nThe main question this study aims to answer is whether histological changes occurring during hypothermic perfusion, alone or in combination with biochemical biomarkers, can accurately predict liver graft viability and post-transplant outcomes. Researchers will also evaluate whether these data can be used to develop an artificial intelligence-based model to support clinical decision-making during organ preservation.\n\nA total of 150 adult liver transplant recipients receiving donor livers treated with HOPE or D-HOPE will be enrolled at three Italian liver transplant centers. Participants will be followed for 90 days after transplantation to assess liver graft function, graft survival, patient survival, and post-transplant complications.\n\nThe results of this study may improve the assessment of donor liver quality before transplantation and help clinicians make more informed decisions about organ use, ultimately increasing the safety and effectiveness of liver transplantation.",[27,29,89,28],"Primary Non-function",[91,92,93,28,94],"liver transplantation","Early Allograft Dysfunction (EAD)","Primary Non-Function (PNF)","Liver Graft Viability Assessment","2026-06-23",{"date":97,"type":39},"2026-06-29",{"date":99,"type":21},"2026-07",{"date":101,"type":21},"2029-06",{"name":45,"class":46}]