[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-transplantation":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,54,0,25,[9,43,68,97,124,155,184,216,241,264,292,336,357,385,415,457,482,506,527,549,577,598,623,646,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100644759","study-of-sleep-quality-and-its-specific-determinants-during-the-care-pathway-of-a-liver-transplant-patient-100644759",false,"NCT07674355","Study of Sleep Quality and Its Specific Determinants During the Care Pathway of a Liver Transplant Patient","LIVERSLEEP","Inclusion Criteria:\n\n* Patients of legal age (age ≥ 18 years)\n* Patients with a liver transplantation indication during the study period\n* Patients who were informed and did not object to their participation in the study\n* Patients affiliated with a social security scheme or beneficiaries of a similar scheme\n\nExclusion Criteria:\n\n* Patients with organ failures whose liver transplantation indication is carried during hospitalization in critical care (very short time between the indication and liver transplantation, causes of medical failure mainly related to the patient's death)\n* Patients with an indication for multi-organ transplantation\n* Narcolepsy\n* Persons deprived of liberty by a judicial or administrative decision\n* People receiving psychiatric care\n* Persons admitted to a health or social welfare institution for purposes other than research\n* Adults subject to a legal protection measure (guardianship, curatorship)\n* Inability to understand the information regarding the protocol","ALL","18 Years",{"count":20,"type":21},108,"ESTIMATED","OBSERVATIONAL","In the LIVERSLEEP study, investigators provide an overview of sleep disorders among patients in a liver transplantation (LT) pathway and a description of the criteria that can influence their sleep.\n\nThis is a prospective longitudinal monocentric pilot study, generating hypotheses whose main objective is to describe the evolution of sleep quality in LT patients between pre-LT evaluation (PLTE) and 6 months post-LT. The secondary objective(s) are, before LT, 2 months and 6 months after, (1) to describe the level of anxiety in our patients, (2) to estimate the proportion of patients with impaired sleep quality, and (3) to describe the characteristics of our patients' sleep.\n\nThis study will cover all adult patients on the LT waiting list at the Croix Rousse Hospital transplant center for the duration of the study. The duration of the inclusion period is 18 months. For each patient, the participation period will be 1 year on average (pre-LT measurement with an average waiting time of 6 months for LT, then measurements at TH+2 months and at TH+ 6 months). The total duration of the study will be 30 months, with a theoretical start of inclusions in the third quarter of 2026.\n\nPatients likely to participate in the study will be identified by the transplant nurse coordinatoir (TNC) within the digestive surgery and LT department of the Croix-Rousse hospital in Lyon. These are all the patients seen in hepatology consultation for the announcement of a LT project. Verification of the selection or contraindication criteria will be carried out by the principal investigator.\n\nDuring the consultation with the hepatologist and the TNC to announce the indication for LT, the study will be presented by the physician and then detailed by the TNC (objectives, steps, submission of upcoming questionnaires). After collecting the patient's non-opposition, clinical data will be collected (weight, height, BMI, sex, age, indication, MELD score, and presence or absence of hepatic encephalopathy). Given the emotional burden of this consultation, no questionnaire will be submitted to the patient at this stage.\n\nDuring the PLTE, then 2 months and 6 months after LT, 5 questionnaires will need to be completed by the patient (evaluation of sleep quality, anxiety, chronotype, physical activity, and pain). The TNC also collects the presence of psychotropic treatments that can influence sleep.\n\nA sleep schedule will be sent to the patient with their appointment for the PLTE and to be completed before hospitalization. This diary will be retrieved during the PLTE by the TNC. The presence or absence of psychotropic treatment will also be recorded.\n\nTwo and six months after the LT, during follow-up visits in ambulatory care, conventional hospitals, or consultations, the patient responds again to these five questionnaires on a tablet, and the TNC also collects the presence of psychotropic treatment.\n\nFinally, at a distance from the LT (2 months later), the TNC collects the duration of the patient's transplant wait (from the date of activation on the waiting list to the LT date), the number of examinations performed during the PLTE, and post-LT complications (return to the operating room, stent-like endovascular treatment, drain adhered to the skin), the duration of the PLTE (date of the first PLTE examination on the date of activation on the waiting list) and the immediate post-LT hospitalization period (in days).\n\nA comparative analysis will be conducted between patients whose sleep quality is altered and those for whom it is maintained, with some factors of interest related to the patient's clinic and care pathway.\n\nThe results will serve as a basis for the implementation of a relevant intervention aimed at treating and reducing sleep disorders in our patients.",[25],"Liver Transplantation",[27,28,29],"Liver transplantation","Quality of sleep","Transplant nurse coordinator (TNC)","NOT_YET_RECRUITING","2026-06-29",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":21},"2026-09",{"date":38,"type":21},"2029-03",{"name":40,"class":41},"Hospices Civils de Lyon","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100641294","effect-of-preoperative-cimt-on-hemodynamics-during-liver-transplantation-100641294","NCT07660679","Effect of Preoperative CIMT on Hemodynamics During Liver Transplantation","The Effect of Preoperative Carotid Intima-Media Thickness on Intraoperative Hemodynamic Profile in Liver Transplant Patients","CIMT-LIVER","Inclusion Criteria:\n\n* Patients aged between 18 and 65 years\n* Scheduled for elective liver transplantation surgery\n* Completed preoperative carotid intima-media thickness (CIMT) ultrasonographic measurement\n* Patients with signed informed consent for data collection\n\nExclusion Criteria:\n\n* Patients undergoing emergency liver transplantation\n* History of previous carotid artery surgery or stenting\n* Known severe carotid artery stenosis (\\>70%)\n* Severe intraoperative hemodynamic instability prior to induction (e.g., active bleeding or shock)\n* Incomplete intraoperative advanced hemodynamic monitoring data or vasopressor records",{"count":5,"type":21},"Candidates for liver transplantation (CT) carry an increased risk of cardiovascular disease (CVD) due to underlying end-stage liver disease (ESHD) and immunosuppressive drugs used post-transplantation. CVD is a significant cause of long-term mortality after CT \\[1\\] \\[2\\]. Carotid Intima-Media Thickness (CIMT), a subclinical marker of atherosclerosis in the preoperative period, is a non-invasive method used to predict future CVD risk \\[3\\]. High CIMT indicates atherosclerosis and decreased arterial compliance. This can compromise organ perfusion and increase the risk of postoperative complications by increasing intraoperative blood pressure variability (BPV) during anesthesia induction and surgical stress in major surgeries such as CT. Studies investigating whether CIMT is an independent risk factor for perioperative hemodynamic instability in CT patients are limited. The aim of our study is to investigate the effect of CIMT values on intraoperative hemodynamic parameters. Secondary objectives are to determine the association of CIMT with the incidence of hypotension, vasopressor requirement, postoperative acute renal injury (ARI), and major cardiac adverse events (MCAE) after anesthesia induction.\n\nTheoretical Benefit: To make a significant contribution to the literature on the relationship between atherosclerosis and anesthesia management by determining whether CIMT is an independent predictor of perioperative hemodynamic instability in chemotherapy patients.\n\nPractical Benefit: To ensure the inclusion of CIMT measurement in the anesthesia risk assessment of chemotherapy candidates. Identifying patients with high CIMT will guide the implementation of more aggressive and targeted hemodynamic management strategies (e.g., more frequent invasive monitoring, proactive vasopressor use) during anesthesia induction and maintenance.",[25,54],"Carotid Intima-media Thickness",[25,56,57],"Hemodynamics","Preoperative Assessment","RECRUITING","2026-06-18",{"date":61,"type":34},"2026-06-23",{"date":63,"type":34},"2026-02-11",{"date":65,"type":21},"2026-07-01",{"name":67,"class":41},"Dicle University",{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100552429","addictological-intervention-in-liver-transplantation-recipients-100552429","NCT06472973","ADDICTOlogical Intervention in LIVEr Transplantation Recipients","AddictoLIVE","Inclusion Criteria:\n\n* Aged 18 years or above\n* Hospitalized for LT for AALD as primary, secondary or tertiary indication\n* Discharged from intensive care unit to hepatology or surgery wards\n\nExclusion Criteria:\n\n* Severe alcohol-associated hepatitis as primary indication for liver transplantation\n* Impossibility of patient follow up over the next 2 years\n* General criteria:\n\n  * Refusal or absence of informed consent,\n  * Non-affiliation to the French national health insurance,\n  * Persons placed under legal protection, guardianship or curatorship",{"count":76,"type":21},720,"INTERVENTIONAL",[79],"NA","Transplantation for end-stage-liver disease (ESLD) in the context of Alcohol-Associated Liver Disease (AALD) has been increasing and represents the main indication for Liver Transplantation (LT) in the world. Alcohol Use Disorder (AUD) is considered a brain chronic disease and requires a transdisciplinary approach that includes medical treatment and behavioral interventions.\n\nIn the context of LT, alcohol relapse occurs in 26 % up to 50% of LT recipients. Among Liver transplant recipients for AALD, severe alcoholic relapse (defined as more than 3 alcoholic drinks per day for women and 4\u002Fday for men) after LT leads to impaired longterm survival due to recurrent alcoholic cirrhosis (RAC), cardiovascular events and de novo cancer.\n\nSeveral strategies have been developed to prevent alcohol relapse. After LT, integrating an addiction team into the LT program has been advocated by the latest guidelines in Europe and the United States, in order to bring the management of alcohol-use disorder (AUD) in transplantation units, through the association of psychosocial and pharmacological interventions previously reported in AALD. However, those guidelines were based on descriptive studies, and the effect of this management needs to be confirmed through a randomized, controlled, multicenter study, involving centers that still do not include an addiction team in their LT programs.\n\nThis study will therefore assess prospectively and comparatively the impact of an addiction intervention after LT on return to alcohol use rates. We hypothesize that standardized targeted addiction monitoring of Liver Transplant recipients decreases the rates of alcohol relapse two years post-liver transplantation.",[82,25],"Alcohol Associated Liver Disease",[27,84,85,86],"Addiction follow-up","Alcohol relapse","Survival","2026-06-17",{"date":89,"type":34},"2026-06-22",{"date":91,"type":34},"2024-11-21",{"date":93,"type":21},"2030-11-21",{"name":95,"class":41},"University Hospital, Montpellier",16,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":77,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100557271","phase-4-influence-of-human-albumin-supplementation-on-kidney-dysfunction-after-liver-transplantation-100557271","NCT06535945","Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation","HALT","Inclusion Criteria:\n\n* Male and female subjects equal or above 18 yrs old.\n* Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).\n* Capability of understanding the purpose and risks of the study.\n* Written informed consent\n\nExclusion Criteria:\n\n* Fulminant hepatitis\n* Kidney injury at baseline (Estimated Glomerular Filtration Rate \\\u003C 50 ml\u002Fmin in Modification of diet in renal disease-6) including hepatorenal syndrome\n* Use of an induction agent Basiliximab at liver transplantation\n* Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty",{"count":105,"type":21},400,[107],"PHASE4","To verify whether albumin administration to achieve serum concentration above 30g\u002FL (treated group) and its maintenance within plasmatic physiologic range (above 30 g\u002FL) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g\u002FL or below (control)).",[25,110],"Acute Kidney Injury",[112,113,114,110],"Liver","Transplantation","Albumin","2026-06-16",{"date":87,"type":34},{"date":118,"type":34},"2025-03-26",{"date":120,"type":21},"2028-04-26",{"name":122,"class":41},"Rennes University Hospital",8,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":77,"phases":133,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100643358","effect-of-discarding-initial-reperfusion-blood-on-hemodynamics-liver-function-and-30-day-outcomes-in-liver-transplantation-100643358","NCT07631689","Effect of Discarding Initial Reperfusion Blood on Hemodynamics, Liver Function, and 30-Day Outcomes in Liver Transplantation","Assessment of the Impact of Discarding the Initial Reperfusion Blood on Early Liver Function, Cardiovascular and Metabolic Changes and on 30-Day Liver and Renal Outcomes. A Prospective Randomized Trial in Liver Transplantation","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Candidates for liver transplantation at Hospital das Clínicas, University of São Paulo Medical School (HCFMUSP)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Previous liver surgery\n* Fulminant hepatitis\n* Specific liver diseases associated with severe electrolyte disturbances\n* End-stage renal disease requiring dialysis\n* Combined organ transplantation\n* Living donor liver transplantation\n* Liver retransplantation\n* Highly sensitized patients with limited availability of blood products\n* Hematologic diseases\n* Portal vein thrombosis involving more than 50% of the lumen\n* Portopulmonary hypertension (mean pulmonary artery pressure \\> 20 mmHg), diagnosed preoperatively or intraoperatively",{"count":132,"type":21},132,[79],"Hepatic reperfusion during liver transplantation remains a critical phase associated with significant hemodynamic and systemic disturbances, despite advances in surgical and anesthetic management. This phase is characterized by the release of acidotic, hypothermic, and hyperkalemic blood containing metabolic byproducts and inflammatory mediators resulting from ischemia-reperfusion injury.\n\nClinically, reperfusion is associated with hemodynamic instability, including reductions in cardiac output and arterial pressure, as well as cardiac dysfunction and arrhythmias, often requiring pharmacologic support. These alterations may affect not only immediate intraoperative stability but also short- and long-term outcomes for both the patient and the graft.\n\nThe abrupt restoration of blood flow to the transplanted liver leads to the systemic release of accumulated metabolites, reactive oxygen species, and inflammatory mediators, contributing to a systemic inflammatory response that may impact distant organs, including the kidneys and heart.\n\nSeveral revascularization strategies have been investigated to mitigate reperfusion-related injury: initial reperfusion via the portal vein, initial reperfusion through the hepatic artery, and simultaneous reperfusion through the portal vein and hepatic artery.\n\nA less frequently used and insufficiently studied strategy, not routinely or systematically implemented, involves diverting the initial reperfusion blood from the graft to the surgical field, followed by the restoration of hepatic blood outflow to the systemic circulation.\n\nThis study hypothesizes that discarding the initial reperfusion blood via the infrahepatic vena cava will attenuate early hemodynamic, metabolic, and inflammatory changes and reduce postoperative complications compared to conventional reperfusion techniques.",[25,136,137],"Ischaemia Reperfusion Injury","Perioperative Complications",[139,140,141,142,143,144,145],"liver transplantation","ischemia-reperfusion injury","liver graft function","anesthesia","inflamatory response","perioperative complications","hemodynamics","2026-06-03",{"date":148,"type":34},"2026-06-08",{"date":150,"type":21},"2026-07",{"date":152,"type":21},"2028-02",{"name":154,"class":41},"University of Sao Paulo General Hospital",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":77,"phases":164,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":42},"100632851","effect-of-preoperative-oral-carbohydrate-loading-on-postoperative-outcomes-in-liver-transplant-patients-100632851","NCT07519057","Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients","Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients: A Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* age ≥ 18 years\n* elective liver transplantation at the Department of General, Transplant, and Liver Surgery, Medical University of Warsaw\n* grafts from brain-dead donors\n* MELD score \\\u003C35\n\nExclusion Criteria:\n\n* acute liver failure\n* insulin-dependent diabetes mellitus\n* gastroparesis\n* mechanical bowel obstruction\n* liver retransplantation within less than 6 months of the primary transplant",{"count":163,"type":21},434,[79],"The aim of the study is to evaluate the effect of preoperative oral carbohydrate loading on postoperative outcomes in liver transplant recipients. The results of this study may contribute to improving recovery after liver transplantation and shortening postoperative hospital stay in these patients.\n\nParticipants will be randomly assigned to either the study group or the control group. Patients assigned to the study group will receive 400 mL of a carbohydrate beverage (Nutricia preOp®), to be consumed up to 2 hours before the anesthesia induction. Patients assigned to the control group will receive 400 mL of a placebo administered in an identical manner as in the study group. Participants will not be informed which group they have been assigned to.\n\nIn the postoperative period, routine laboratory and imaging tests will be performed, and their results will be used to assess the effects of the intervention. Follow-up of the patient's clinical course is planned for up to 30 days after surgery. The schedule of follow-up visits will not differ from standard clinical practice.",[25,167,168,169],"Liver Transplant","Liver Transplant Surgery","End Stage Liver Disease",[171,172,173,25,167,174,175],"Preoperative Oral Carbohydrate Loading","POCL","Nutricia PreOp","Carbohydrate drink","Preoperative Carbohydrate Loading","2026-06-01",{"date":146,"type":34},{"date":179,"type":34},"2026-05-27",{"date":181,"type":21},"2028-08",{"name":183,"class":41},"Medical University of Warsaw",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100640555","establishing-a-reference-framework-for-outcomes-after-machine-preserved-liver-transplantation-in-europe-100640555","NCT07585890","Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe","Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)","REFRAME-MP","Inclusion Criteria:\n\n* All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients \\>18 years at the time of liver transplantation.\n* All donor types (DBD, DCD)\n* Preservation either with static cold storage alone or combined with machine perfusion (MP).\n* Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.\n* Eligible MP protocols are:\n\n  1. end-ischemic single- or dual hypothermic oxygenated MP \\[e(D)HOPE\\],\n  2. end-ischemic (back-to-base) normothermic MP \\[eNMP\\],\n  3. continuous (device-to-donor) normothermic MP \\[cNMP\\],\n  4. e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP \\[e(D)HOPE-COR-NMP)\\],\n  5. e(D)HOPE followed by normothermic MP \\[e(D)HOPE-NMP\\], or\n  6. Normothermic regional perfusion followed by SCS or an ex situ MP protocol.\n* A minimum follow-up of 12 months after liver transplantation is required.\n\nExclusion Criteria:\n\n* Livers that were allocated to a MP protocol as part of a prospective randomized or interventional clinical trial comparing different preservation techniques or any other invention.\n* Living donor liver transplantation",{"count":193,"type":21},10000,"Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Consequently, many studies continue to reference historical benchmark cohorts from the pre-perfusion era, or use risk scores developed before routine utilization of MP. These cohorts, while once valuable, fail to account for the paradigm shift that MP has introduced. Likewise, commonly used donor- and recipient-based risk scores were developed prior to the adoption of MP. While these scores aim to assess survival or morbidity after transplantation, none of them guide decisions about MP use or the most suitable perfusion protocol. As MP technologies continue to evolve there is a critical need for an updated reference framework that accurately reflects current clinical practice and captures the best achievable outcomes across all MP modalities.",[196,197,198,25],"End-stage Liver Disease (ESLD)","Acute Liver Failure","Liver Cirrhosis",[200,139,201,202,203,204,205],"machine perfusion","hypothermic machine perfusion","normothermic machine perfusion","normothermic regional perfusion","organ preservation","machine preservation","2026-05-11",{"date":208,"type":34},"2026-05-14",{"date":210,"type":34},"2026-04-21",{"date":212,"type":21},"2030-12-31",{"name":214,"class":41},"University Medical Center Groningen",2,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100640101","impact-of-the-procurement-technique-on-outcomes-after-liver-transplantation-100640101","NCT07582978","Impact of the Procurement Technique on Outcomes After Liver Transplantation","Impact of the Procurement Technique on Outcomes After Liver Transplantation: a French Multicenter Prospective Study","PLVT_TH","Inclusion Criteria:\n\n1. Patients aged 18 years or older at the time of inclusion\n2. Listed on the national waiting list of the Agence de la Biomédecine (ABM)\n3. Undergoing a first liver transplantation in France\n4. Receiving a whole liver graft\n5. No prior or subsequent transplantation of another organ\n\nExclusion Criteria:\n\n1. Pancreas procurement\n2. Multiorgan transplantation\n3. Split liver transplantation (shared grafts)\n4. Retransplantation\n5. Domino transplantation (no actual organ procurement in the conventional sense)\n6. Patient refusal to allow the use of their data",{"count":225,"type":21},1810,"Liver transplantation (LT) is the standard treatment for hepatocellular carcinoma (HCC) and end-stage liver disease, with excellent long-term outcomes despite the increasing use of extended criteria donors due to organ shortage. As traditional evaluation criteria have become insufficient, new indicators such as Arterial and Biliary Complication-Free Survival (ABCFS) have been developed to better assess post-transplant outcomes.\n\nPrimary objective: To assess, in a large-scale study, whether the procurement technique influences liver transplantation outcomes in terms of arterial and biliary complication-free survival.",[25],[139,229,230,231,232],"LT","hepatocellular carcinoma (HCC)","Arterial and Biliary Complication-Free Survival","procurement technique","2026-05-07",{"date":235,"type":34},"2026-05-13",{"date":36,"type":21},{"date":238,"type":21},"2031-09",{"name":240,"class":41},"Assistance Publique - Hôpitaux de Paris",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":251,"studyType":22,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":260,"leadSponsor":262,"locationsCount":42},"100635002","hemodynamic-profiles-and-macro-microcirculatory-coherence-in-liver-transplantation-an-integrative-approach-in-the-immediate-postoperative-period-100635002","NCT07547020","Hemodynamic Profiles and Macro-Microcirculatory Coherence in Liver Transplantation: an Integrative Approach in the Immediate Postoperative Period","Hemodynamic Profiles and Macro-Microcirculatory Coherence in Liver Transplantation: An Integrative Approach to the Immediate Postoperative Period","COHERENCE-LT","Inclusion Criteria: Consecutive adult patients (≥18 years) admitted to the intensive care unit in the immediate postoperative period following liver transplantation with hemodynamic instability.\n\n\\-\n\nExclusion Criteria: Primary graft failure.\n\n\\-",{"count":250,"type":21},60,"30 Days","Hemodynamic instability is a common and serious condition in patients undergoing liver transplantation and is associated with increased morbidity and mortality if not promptly recognized and treated. It results from multiple interacting factors, including blood loss, changes in vascular tone, cardiac dysfunction, and complications related to the surgical procedure.\n\nTraditional monitoring strategies focus on global hemodynamic variables such as blood pressure and cardiac output. However, these parameters may not accurately reflect tissue perfusion or oxygen delivery at the microcirculatory level. As a result, patients may appear hemodynamically stable while still experiencing inadequate tissue oxygenation.\n\nThis study aims to evaluate hemodynamic instability using an integrative physiological approach based on the interaction between different components of the cardiovascular system. Specifically, the study will assess four key interfaces: the relationship between the heart and the arterial system, the coherence between macrocirculation and microcirculation, the interaction between venous return and the right atrium, and the coupling between the right ventricle and the pulmonary circulation.\n\nThe main objective is to identify distinct hemodynamic profiles in patients during the immediate postoperative period following liver transplantation. In addition, the study will evaluate the incidence of tissue hypoxia within the first 24 hours and its association with clinical outcomes, including 30-day evolution.\n\nThis is a prospective observational study conducted in adult patients admitted to the intensive care unit after liver transplantation who develop hemodynamic instability requiring vasoactive support. During the first 24 hours, multimodal hemodynamic monitoring will be performed, including assessment of cardiac function, vascular tone, venous congestion, pulmonary circulation, and markers of tissue perfusion such as lactate levels and capillary refill time.\n\nBy integrating these variables, patients will be classified into different hemodynamic profiles according to the predominant underlying mechanism. This approach aims to improve the understanding of cardiovascular dysfunction in this setting and to support more individualized and physiologically guided management strategies.",[25,254,255],"Shock","Hemodynamic Instability","2026-04-27",{"date":258,"type":34},"2026-05-01",{"date":258,"type":21},{"date":261,"type":21},"2027-09-01",{"name":263,"class":41},"Hospital El Cruce",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":77,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":42},"100616350","effects-of-terlipressin-and-somatostatin-on-portal-pressure-in-patients-undergoing-living-donor-liver-transplantation-100616350","NCT07304466","Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation","Comparison of the Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation","Inclusion Criteria:\n\nPatients scheduled for right lobe living donor liver transplantation with clinically significant portal hypertension (esophageal varices, thrombocytopenia (\\\u003C100,000), ascites, encephalopathy; Child-Turcotte-Pugh class B-C)\n\nExclusion Criteria:\n\n* Allergy to any of the medications to be used\n* Portal vein thrombosis\n* Being treated with terlipressin with a diagnosis of hepatorenal syndrome\n* Portopulmonary hypertension\n* Acute on chronic liver failure\n* Chronic renal failure (glomerular filtration rate ≤ 30%)\n* Myocardial ischemia\n* Uncontrolled hypertension\n* Arrhythmia\n* Multiple solid organ transplantation","70 Years",{"count":273,"type":21},50,[79],"The goal of this clinical trial is to compare the effects of somatostatin and terlipressin on lowering portal pressure in patients with portal hypertension undergoing liver transplantation, and to investigate whether there are differences in clinical outcomes between the two drugs. The study will evaluate the decrease in portal pressure from baseline following drug administration at defined time points. It will also compare the effects of these drugs on hemodynamics, bleeding, and transfusion requirements. After baseline intraoperative direct portal pressure measurement, a bolus dose of the study drug will be administered, followed by continuous intravenous infusion intraoperatively and for 24 hours postoperatively. Direct portal pressure will be measured again 5 minutes after the bolus dose, after the portal vein anastomosis, after the hepatic artery anastomosis, and, if performed after splenic artery ligation. Hemodynamic parameters will be recorded, and the drugs will be compared in terms of their intraoperative hemodynamic effects. As elevated portal pressure is associated with increased bleeding, intraoperative blood loss and transfusion needs will also be assessed between the groups. Patients will be followed for 7 days postoperatively for clinical and laboratory outcomes.",[25,277],"Portal Hypertension",[139,279,280,281,282,283],"portal pressure","portal hypertension","living donor liver transplantation","somatostatin","terlipressin",{"date":285,"type":34},"2026-04-29",{"date":287,"type":34},"2025-12-29",{"date":289,"type":21},"2027-03-30",{"name":291,"class":41},"Istanbul Medipol University Hospital",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":271,"enrollmentInfo":300,"targetDuration":4,"studyType":77,"phases":302,"briefSummary":303,"conditions":304,"keywords":309,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":215},"100636088","nutrition-and-exercise-prehabilitation-in-patients-awaiting-liver-transplantation-100636088","NCT07561138","Nutrition and Exercise Prehabilitation in Patients Awaiting Liver Transplantation","Evaluation of Protein Distribution Optimization With Exercise Regimen on Nutritional Status, Body Composition and Functional Status in Patients Awaiting Liver Transplantation: The POWER-LT Randomized Clinical Trial","POWER-LT","Inclusion Criteria:\n\n* End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture\n* Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation\n* No prior formal dietary advice\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Estimated waiting time for liver transplantation \\\u003C 3 months\n* Estimated life expectancy \\\u003C 3 months\n* Chronic kidney disease requiring protein restriction\n* Exercise contraindicated (e.g., active or recent variceal bleeding, severe grade of hepatic encephalopathy, refractory ascites, etc.)\n* Unstable or severe psychiatric disorder\n* Pregnancy or lactation\n* Inability to provide written informed consent",{"count":301,"type":21},90,[79],"This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients awaiting liver transplantation.",[305,198,25,306,307,308],"End-stage Liver Disease","Malnutrition","Sarcopenia","Frailty",[310,311,312,139,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327],"liver disease","end-stage liver disease","liver cirrhosis","malnutrition","sarcopenia","frailty","diet","nutrition","nutrition therapy","protein","protein distribution","exercise","prehabilitation","nutritional status","body composition","functional status","physical performance","quality of life","2026-04-24",{"date":258,"type":34},{"date":331,"type":34},"2026-01-08",{"date":333,"type":21},"2029-07",{"name":335,"class":41},"Kalliopi Anna Poulia",{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":77,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":4},"100586511","open-label-trial-of-deceased-donor-livers-transplanted-after-dhope-with-exvivo-liver-perfusion-100586511","NCT06916325","Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion","DeLIVER Trial: A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion","Participant Inclusion Criteria:\n\n1. Participant is able to provide informed consent and HIPAA authorization\n2. Age ≥18 years\n3. Participant is registered as an active first-time liver transplant candidate on the United Network for Organ Sharing (UNOS) waiting list for primary liver transplantation\n\n   \\- For participants with hepatocellular carcinoma (HCC) as indication for Orthotopic Liver Transplantation, the tumor must be within Milan Criteria or down-staged to Milan Criteria at the time of transplant\n4. Participant is willing to comply with the study requirements and procedures\n\nParticipant Exclusion Criteria:\n\n1. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)\n2. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)\n3. Participant is listed for a repeat liver transplantation (\\>1 graft)\n4. Participant is pregnant\n5. Participant is on respiratory (ventilator dependent) and\u002For cardiocirculatory support (defined as mechanical circulatory support which requires at least one intravenous inotrope to maintain hemodynamics)\n6. Participant is enrolled in an interventional clinical trial with an investigational drug or device\n7. Presence of other medical, social, or psychological conditions that in the investigator's opinion, could limit the participant's ability to participate in the clinical trial",{"count":344,"type":21},215,[79],"The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.",[168,25],"2026-04-16",{"date":210,"type":34},{"date":351,"type":21},"2027-01",{"date":353,"type":21},"2033-04",{"name":355,"class":356},"XVIVO Perfusion","INDUSTRY",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":77,"phases":367,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":382,"locationsCount":384},"100583282","assessing-declined-liver-grafts-with-normothermic-machine-perfusion-to-reduce-transplant-waiting-time-100583282","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",{"count":366,"type":21},186,[79],"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.",[25,370,371],"Liver Diseases","Surgery",[25,373,374,375],"Extended Criteria Donors","Normothermic Machine Perfusion","Discarded Liver Grafts","2026-04-14",{"date":378,"type":34},"2026-04-15",{"date":380,"type":34},"2025-06-02",{"date":212,"type":21},{"name":383,"class":41},"Charite University, Berlin, Germany",10,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":77,"phases":395,"briefSummary":396,"conditions":397,"keywords":399,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"100543308","phase-4-evaluation-of-the-benefits-of-administering-immunosuppressive-drugs-as-single-daily-doses-over-the-first-year-after-liver-transplantation-easy-100543308","NCT06354179","Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)","Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation","EASY","Inclusion Criteria:\n\n* Recipients of a first liver allograft from a deceased donor\n* Transplanted for less than four weeks at enrolment.\n* Without inter-current progressive life-threatening or graft-threatening disease.\n* Having signed a written informed consent for their participation in the study.\n* Affiliated to, or beneficiary of, a social security regimen\n\nExclusion Criteria:\n\n* Recipients of a split-liver transplantation.\n* Recipients of any transplanted organ other than the liver\n* Patient who has undergone colon resection\n* Patients under legal protection (guardianship, curatorship).\n* Patient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®.\n* Patients in whom everolimus-based calcineurin inhibitors (CNI) minimization is anticipated\n* Patients treated with HIV or HCV protease inhibitors.\n* Pregnant or lactating women.\n* Women of childbearing potential without any effective contraceptive method (according to the guidelines of CTFG, Clinical Trial Facilitation Group, related to contraception and pregnancy test in clinical trials) or not practicing sexual abstinence.\n* Sexually active men having a female partner, without any effective contraception.\n* Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.\n* Patients enrolled in another clinical study evaluating drugs or therapeutic strategies potentially interfering with the objectives of the EASY study.",{"count":394,"type":21},162,[107],"World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.\n\nThe immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.\n\nAlthough the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.\n\nThe narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.\n\nLimited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.\n\nEven if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.\n\nIn this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®.",[25,398],"Immunosuppression",[139,400,401,402,403,404],"immunosuppression","tacrolimus","mycophenolate","adherence","once-daily intake","2026-03-16",{"date":407,"type":34},"2026-03-19",{"date":409,"type":34},"2025-04-15",{"date":411,"type":21},"2028-04-15",{"name":413,"class":41},"University Hospital, Limoges",18,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":77,"phases":425,"briefSummary":428,"conditions":429,"keywords":437,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":42},"100613626","phase-1-immune-tolerance-induction-after-liver-transplantation-100613626","NCT07269041","Immune Tolerance Induction After Liver Transplantation","A Phase I Feasibility Study of HSPC Infusion Following Total Lymphoid Irradiation and Anti-thymocyte Globulin in Patients With a Pre-existing, Well-functioning HLA-matched Living-donor Liver Transplant to Induce Immune Tolerance.","iTILT","Recipient Inclusion Criteria:\n\n1. Males and females ages 18 years and older with a pre-existing liver transplant from a living donor with a donor-recipient match at 6 or more out of 12 alleles across the HLA-A, -B, -C, -DR, -DQ, and -DP loci, as determined by high-resolution HLA typing.\n2. Pre-existing living-donor liver transplant must be 12 months to 20 years from date of scheduled HSPC infusion.\n3. Agreement to participate in the study and ability to give informed consent.\n4. Liver biopsy within 4 weeks of enrollment without signs of rejection.\n5. Meets institutional criteria for HSPC infusion.\n6. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three months of the trial at the physician's discretion.\n7. No known contraindication to administration of rATG or radiation therapy.\n8. If subject is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status), subject must be confirmed not pregnant by a serum or urine pregnancy test and must agree to practice a reliable form of contraception including hormonal treatments, barrier methods or intrauterine device for at least 12 months following initiation of the tolerance protocol.\n\nRecipient Exclusion Criteria:\n\n1. Major ABO incompatibility with donor.\n2. Any of the following labs \\> 2.0 times the upper limit of normal on screening: AST, ALT, ALP, GGT or TBil.\n3. History of rejection with current HLA-matched liver transplant within the last year.\n4. History of GVHD following liver transplant.\n5. Positive Class II HLA Donor-Specific Antibody (DSA) or class I DSA specificity above 5,000 MFI at the time of the stem cell infusion.\n6. History of multi-organ transplantation, either simultaneous or as separate events.\n7. History of more than one liver transplant.\n8. Known allergy to rabbit proteins.\n9. History of a major post-transplant complication at investigator discretion.\n10. History of active malignancy within the past 5 years except for:\n\n    1. Malignancy that has not required treatment in the past on active surveillance.\n    2. Malignancy treated with curative intent with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence.\n    3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n    4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, DCIS).\n11. Active bacterial, fungal or mycobacterial infection.\n12. Clinically significant viremia from EBV, CMV, HCV or HBV PCR test within the past 3 months.\n\n    1. Significant CMV viremia is defined as greater than or equal to 137 IU\u002FmL.\n    2. If CMV low-level viremia is detected, defined as 137 - 1,000 IU\u002FmL, patients may undergo subsequent testing up to twice per week and two consecutive negative results will allow for inclusion.\n13. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, or HTLV I or II by serum antibody testing.\n14. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n15. Active extra-hepatic autoimmune disease requiring immunosuppression.\n16. Autoimmune disease was the indication for liver transplantation.\n17. Any condition that precludes the ability to give informed consent and\u002For places the subject at high risk for non-compliance with the safety monitoring requirements of the study.\n18. Received immunotherapy drugs, such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, or interleukin-2 within six months of the study treatment.\n19. Use of medications with known hepatotoxicity or potential to confound interpretation of liver function tests (e.g., methotrexate, isoniazid, amiodarone), unless reviewed and approved by the Principal Investigator and hepatology, and the subject has demonstrated stable liver function tests for ≥6 months while on the medication.\n20. Active hepatobiliary and pancreatic diseases:\n\n    1. History of chronic hepatobiliary or pancreatic disorders that may interfere with safety assessments or interpretation of protocol endpoints, including but not limited to primary sclerosing cholangitis (PSC), autoimmune hepatitis, primary biliary cholangitis (PBC), chronic pancreatitis, recurrent cholangitis, biliary strictures, biliary obstruction, untreated bile duct injury, hepatobiliary malignancy, or metabolic\u002Fgenetic liver disease (e.g., Wilson's disease, alpha-1 antitrypsin deficiency).\n    2. Active chronic liver diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease.\n    3. Gallbladder diseases such as cholecystitis or symptomatic cholelithiasis.\n\nDonor Inclusion Criteria:\n\n1. Males and females ages 18 years and older meeting the HLA-matching requirements specified in the \"Recipient Inclusion Criteria\" above.\n2. Must meet the following criteria for HSPC donation:\n\n   1. Hgb: \\> 11 g\u002Fdl\n   2. Plt: \\> 80,000\u002FµL\n   3. WBC: \\> 3,000\u002FµL\n\nDonor exclusion criteria:\n\n1. Major ABO incompatibility with recipient.\n2. Medically unfit to tolerate peripheral blood apheresis (e.g., small body size, poor vascular access, not a suitable candidate for placement of a central catheter).\n3. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n4. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, HTLV I or II by serum antibody testing.\n5. Active West Nile Virus infection.\n6. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and\u002For C).\n7. Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study\n8. Use of oral anticoagulants within two days of apheresis.\n9. History of active malignancy within the past 5 years except for:\n\n   1. Malignancy that has not required treatment in the past on active surveillance.\n   2. Malignancy treated with curative intent with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence.\n   3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, DCIS).",{"count":424,"type":21},12,[426,427],"PHASE1","PHASE2","This clinical trial is being conducted to help liver transplant recipients safely discontinue toxic immunosuppressive drugs years after surgery. Lifelong use of these drugs is the current standard, but they come with life-threatening side effects. UCLA has pioneered this \"Delayed Tolerance\" approach, achieving success in numerous kidney recipients now living drug-free. The process uses a conditioning regimen followed by donor stem cell infusion to retrain the immune system to accept the liver as \"self.\"",[25,430,431,432,433,434,435,436,169],"Immune Tolerance","Immune Tolerance\u002FDrug Effects","Graft Survival","Hematopoietic Stem Cell","Chimerism","Immunosuppression After Liver Transplantation","Immunosuppression Disorders",[25,430,438,434,439,440,441,442,443,444,445,446,447],"Hematopoietic Stem Cell Infusion","Mixed Chimerism","Total Lymphoid Irradiation","Antithymocyte Globulin","Immunosuppression Withdrawal","Living Donor Liver Transplant","Tolerance Induction","Delayed Immune Tolerance","Retroactive Immune Tolerance","Immunosuppression Toxicity","2026-03-10",{"date":450,"type":34},"2026-03-12",{"date":452,"type":34},"2026-02-20",{"date":454,"type":21},"2033-01",{"name":456,"class":41},"University of California, Los Angeles",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":464,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":466,"conditions":467,"keywords":470,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":42},"100624781","multidimensional-frailty-assessment-and-post-transplant-outcomes-in-liver-transplant-candidates-100624781","NCT07414095","Multidimensional Frailty Assessment and Post-Transplant Outcomes in Liver Transplant Candidates","Investigation of the Relationship Between Frailty, Sarcopenia, Malnutrition, and Psychosocial Parameters and Post-Transplant Outcomes in Liver Transplant Candidates","Inclusion Criteria:\n\n* Being listed as a liver transplant candidate\n* Age between 18 and 65 years\n* Ability to understand the Turkish language\n\nExclusion Criteria:\n\n* Presence of orthopedic and\u002For neurological problems severe enough to prevent completion of assessment tools\n* Inability to understand verbal commands\n* Being a recipient of multiple organ transplants\n* Presence of serious active extrahepatic malignancy","65 Years",{"count":250,"type":21},"This study will evaluate frailty, nutrition, sarcopenia, and psychological health in people waiting for a liver transplant. The purpose is to understand how these factors affect outcomes before and after transplantation. By identifying patients at higher risk early, the study aims to support the development of better care programs in the future.\n\nParticipants will complete simple tests of physical strength, walking speed, and daily activity levels. Their nutrition and psychological well-being will also be assessed. The study will then look at how these results relate to medical scores used in liver disease and to outcomes after transplant, such as hospital stay, complications, or survival.\n\nAdults aged 18-65 years who are on the liver transplant waiting list and can understand Turkish are eligible to join.",[468,25,469],"End-Stage Liver Disease","Cirrhosis",[471,308,307,306,472],"Liver Transplant Candidates","Psychosocial Health","2026-02-12",{"date":475,"type":34},"2026-02-17",{"date":477,"type":34},"2025-12-15",{"date":479,"type":21},"2026-08",{"name":481,"class":41},"Izmir Bakircay University",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":464,"enrollmentInfo":489,"targetDuration":4,"studyType":77,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":42},"100618083","the-effectiveness-of-telerehabilitation-in-liver-transplant-patients-100618083","NCT07327008","The Effectiveness of Telerehabilitation in Liver Transplant Patients","Investigation of the Effectiveness of the Telerehabilitation Program in Patients With Liver Transplantation","Inclusion Criteria:\n\n* Being between 18-65 years of age and having undergone a liver transplant\n* Having had a liver transplant operation at least 6 months prior\n* Spontaneous breathing\n* Hemodynamic stability\n* Reading and writing skills\n* Ability to mobilize independently, ability to follow verbal and visual instructions\n\nExclusion Criteria:\n\n* Presence of unstable cardiovascular disease\n* Presence of primary lung disease requiring regular bronchodilator treatment\n* Presence of neuromuscular disease or neurological complications\n* Musculoskeletal limitation\u002Fuse of assistive devices\n* Being a multiple organ transplant recipient\n* Presence of orthopedic disability and functional capacity limitation",{"count":490,"type":21},58,[79],"Liver transplantation is defined as a surgical procedure in which a liver with tissue damage and inability to perform its functions is replaced, in whole or in part, with a healthy liver obtained from a living or deceased donor. Post-transplantation treatment includes medical treatment, physiotherapy, and rehabilitation. Physiotherapy and rehabilitation, an important component of liver transplantation management, consists of three phases: preoperative, early postoperative, and late postoperative. Telerehabilitation is currently defined as the control or monitoring of rehabilitation remotely using telecommunication-related technologies. Studies on telerehabilitation in liver transplant patients are insufficient in the literature. The aim of this study is to investigate the effect of a telerehabilitation-based exercise program applied to liver transplant patients on exercise capacity, respiratory muscle strength, peripheral muscle strength, fatigue level and quality of life.",[25,494],"Telerehabilitation",[139,496,321,327],"telerehabilitation","2026-01-09",{"date":499,"type":34},"2026-01-12",{"date":501,"type":21},"2026-02-01",{"date":503,"type":21},"2026-07-30",{"name":505,"class":41},"Istanbul University - Cerrahpasa",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":77,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":42},"100414149","mediterranean-diet-post-liver-transplantation-100414149","NCT04672863","Mediterranean Diet Post-liver Transplantation","Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation","Inclusion Criteria\n\n* Adult patients ≥ 18 years of age undergoing primary liver transplant\n* Ascites-adjusted BMI ≥ 25 kg\u002Fm2\n* Acceptable graft function (total bilirubin level \\\u003C 5 mg\u002FdL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)\n\nExclusion Criteria\n\n* Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology\n* Untreated post-transplant vascular complications or biliary strictures\n* Multi-organ transplantation\n* Urine protein excretion ≥2.0 g\u002Fday\n* Uncontrolled diabetes mellitus (HbA1c \\> 10%)\n* Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders\n* Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)\n* History of bariatric surgery\n* Pregnancy or planning on pregnancy in the next year",{"count":514,"type":21},80,[79],"The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.",[25],"2026-01-05",{"date":520,"type":34},"2026-01-07",{"date":522,"type":34},"2021-01-19",{"date":524,"type":21},"2027-11",{"name":526,"class":41},"Mayo Clinic",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":533,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":4},"100616840","a-retrospective-study-of-safety-and-efficacy-of-locoregional-therapies-combined-with-anti-vegftkis-and-immune-checkpoint-inhibitors-for-all-comers-of-intention-to-treat-patients-with-hepatocellular-carcinoma-beyond-ucsf-criteria-before-liver-transplantation-100616840","NCT07310836","A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF\u002FTKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Hepatocellular Carcinoma Beyond UCSF Criteria Before Liver Transplantation","Inclusion Criteria:\n\n* Age ≥16;\n* Clinical diagnosis of HCC;\n* CNLC Stage I-IIIA.\n\nExclusion Criteria:\n\n* Extrahepatic metastasis;\n* Type IV portal vein tumor thrombus.","16 Years",{"count":535,"type":21},300,"This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined treatment strategy for patients with hepatocellular carcinoma (HCC) who are beyond the UCSF criteria but intended for liver transplantation. The primary objective is to assess the outcomes of these \"intention-to-treat\" patients who received locoregional therapies (LRT, such as TACE or radiotherapy) in combination with systemic therapy (anti-VEGF\u002FTyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors) as a \"conversion therapy\" prior to potential transplantation. This approach is distinct from traditional bridging or down-staging therapies by incorporating more aggressive systemic regimens. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients beyond UCSF criteria who received the combined conversion therapy between January 2020 and December 2024. A control group of about 200 patients who met the UCSF criteria and were directly listed for transplantation in the same period will be used for comparison. Data will be collected from medical records and the China Liver Transplant Registry (CLTR), with follow-up until December 2025.\n\nPrimary outcome measures include:\n\nObjective Response Rate (ORR) of conversion therapy per mRECIST. Rate of successful down-staging to meet UCSF criteria.\n\n1-, 2-, and 3-year overall survival (OS) rates of the intention-to-treat population.\n\nActual liver transplantation rate after successful conversion. Post-transplant 1-, 2-, and 3-year OS and recurrence-free survival (RFS) rates.\n\nSecondary outcomes involve:\n\nSafety profiles of both conversion therapy and subsequent transplantation. Analysis of factors influencing conversion success and treatment efficacy. Determination of an optimal washout period for Immune Checkpoint Inhibitors prior to transplantation.\n\nThe study seeks to provide high-level evidence for optimizing pre-transplant conversion strategies for advanced HCC patients currently outside standard transplant criteria.",[538,25],"Hepatocellular Carcinoma","2025-12-16",{"date":541,"type":34},"2025-12-30",{"date":543,"type":21},"2025-12-20",{"date":545,"type":21},"2026-03-31",{"name":547,"class":548},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":77,"phases":559,"briefSummary":560,"conditions":561,"keywords":564,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":576},"100571259","phase-4-hope-against-cancer-recurrence-in-hcc-100571259","NCT06717919","HOPE Against Cancer Recurrence in HCC","Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT","HOPE4Cancer","Inclusion Criteria:\n\n* Adult recipients (\\>18y), listed for liver transplantation with documented HCC (Liver Imaging Reporting and Data System (LIRADS) 5 lesion in magnetic resonance imaging or computer tomography of the liver or biopsy proven),\n* within up to seven criteria, i.e. HCC with seven as the sum of the diameter of the largest tumour (in cm) and the number of tumours at the time point of liver transplantation,\n* written informed consent for the trial. This also includes patients beyond the up to seven criteria after successful downsizing of the HCC\n\nExclusion Criteria:\n\n* Donation after circulatory death (DCD) liver grafts\n* Combined liver transplants\n* Partial liver transplants\n* Combined or mixed hepatocellular cholangiocarcinoma (cHCC-CCC) or pure cholangiocarcinoma or other malignancies in histopathology of the liver explant\n* Systemic antitumoural medical treatment with checkpoint inhibitors or multikinase inhibitors\n* Post-transplant treatment with mTOR inhibitors\n* Acute and unexpected medical contraindications\n* Pregnancy\n* Cold storage time of \\> 10 hours (both study arms)",{"count":558,"type":21},220,[107],"Liver transplantation is often performed to treat liver cancer, or hepatocellular carcinoma (HCC), in patients with impaired liver function due to cirrhosis. A shortcoming, however, is tumor recurrence after transplantation. Approximately 15 % of patients receiving livers develop recurrence and this depends on the quality of the liver received.\n\nMachine liver perfusion, for example, hypothermic oxygenated liver perfusion (HOPE), which means that the organ is perfused with an oxygen-rich fluid in a cold environment before transplantation, is a novel method to improve the quality of livers before implantation. The standard of care is cold storage without perfusion.\n\nThe objective of this study is to compare the survival after tumor recurrence of patients after liver transplantation for HCC between perfused and not perfused livers. This study's hypothesis is that survival without tumor recurrence is improved when the liver is perfused before implantation.\n\nThe study involves transplant centers worldwide, and adults with HCC waiting for liver transplantation are included. 220 Patients will be recruited within 12 months and then observed for at least 2 years after transplantation. To provide the most valid results, the patients will be randomly allocated to either the organ perfusion group or a control group with standard-of-care cold storage of the organ.",[25,562,563],"HCC","Oncological Outcomes",[565,566,567,568,139],"HOPE","randomised controlled trial","multicentre","hepatocellular carcinoma",{"date":539,"type":34},{"date":571,"type":34},"2025-08-01",{"date":573,"type":21},"2028-01-31",{"name":575,"class":41},"Philipp Dutkowski",37,{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":4},"100614085","efficacy-and-prognosis-of-auxiliary-liver-transplantation-100614085","NCT07275008","Efficacy and Prognosis of Auxiliary Liver Transplantation","Efficacy and Long-term Prognosis of Auxiliary Liver Transplantation","Inclusion Criteria:\n\n1. Patients who underwent auxiliary liver transplantation or living donor liver transplantation (LDLT).\n2. Patients with complete medical records and follow-up data.\n\nExclusion Criteria:\n\n1. Patients who underwent retransplantation.\n2. Patients who underwent other organ transplantation (or multiorgan transplantation).\n3. Patients with severe missing postoperative follow-up data or loss to follow-up.",{"count":585,"type":21},100,"The objective of this observational study is to systematically compare the efficacy and patient prognosis between auxiliary liver transplantation and living donor liver transplantation, and to explore the postoperative recovery, survival rate, rejection, postoperative complications, and long-term prognosis of patients undergoing auxiliary liver transplantation.",[25,588],"Auxiliary Liver Transplantation","2025-12-09",{"date":591,"type":34},"2025-12-10",{"date":593,"type":21},"2025-12-01",{"date":595,"type":21},"2029-12-31",{"name":597,"class":41},"Zhi-Jun Zhu",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":77,"phases":608,"briefSummary":609,"conditions":610,"keywords":612,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":42},"100605062","efficacy-and-safety-of-tranexamic-acid-in-adult-liver-transplantation---esta-trial-100605062","NCT07157631","Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial","A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation (ESTA Trial)","ESTA","Inclusion Criteria:consenting adults aged at least 18 years who are scheduled for allogeneic liver transplantation with general anesthesia.\n\n\\-\n\nExclusion Criteria:1) History of arterial or venous thrombosis within 3 months; 2) Re-transplantation; 3) Known allergy to tranexamic acid; 4) Participation in potentially conflicting clinical trials; 5) Considered by the responsible surgeon or anesthesiologist to be unsuitable.\n\n\\-",{"count":607,"type":21},1546,[79],"We propose a multi-center randomized trial to test the primary hypothesis that tranexamic acid is superior to placebo on blood loss in adult orthotopic liver transplantation within the initial 24 hours and that tranexamic acid is non-inferior to placebo for a composite of thrombotic events within the initial 7 postoperative days. Secondarily, we will determine whether tranexamic acid is superior to placebo on total postoperative drainage volume and blood product transfusion within the initial 3 postoperative days.\n\nWe propose to randomize patients to 2.0 g of tranexamic acid intravenously at the start of surgery or a comparable volume of 0.9% normal saline placebo. Because demonstrating safety will require more patients, our sample size is based on safety. Randomizing 1546 patients will provide 80% power for detecting a non-inferiority margin of 4% with a baseline incidence of 10% for composite thrombotic events within the initial 7 postoperative days.",[25,611,196],"Tranexamic Acid",[25,613],"tranexamic acid","2025-12-02",{"date":616,"type":34},"2025-12-08",{"date":618,"type":34},"2025-11-01",{"date":620,"type":21},"2027-12-01",{"name":622,"class":41},"RenJi Hospital",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":630,"enrollmentInfo":631,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":645,"locationsCount":215},"100464338","renal-biopsies-in-post-liver-transplantation-patients-with-renal-impairment-100464338","NCT05326399","Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment","Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment: a Single-center, Prospective Cohort Study","Inclusion Criteria:\n\n* age 18-75 years\n* patients received liver transplantation\n* new onset of proteinuria(defined as 24-hour proteinuria\\>1g\u002F24h, or Urinary albumin creatinine ratio(UACR)\\>300mg\u002Fg on at least two occasions), and\u002For renal impairment: eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² at least two occasions, and\u002For serum creatinine increase ≥50% from baseline\n* have received renal biopsy in the past 3 months\n* Signed informed consent form(ICF)\n\nExclusion Criteria:\n\n* patients received renal transplantation\n* hepatic failure\n* severe bleeding risk or platelet \\\u003C70\\*109\u002FL\n* chronic kidney insufficiency with eGFR\\\u003C30ml\u002Fmin·1.73m2,or kidney atrophy, or solitary kidney, or medullary sponge kidney, or polycystic kidney, or obstructive nephropathy\n* uncontrolled mental disease or unable to cooperate during operation\n* Pregnancy or lactation\n* not suitable for this study judged by investigaters","75 Years",{"count":632,"type":21},369,"Investigators will conduct this single-center, prospective cohort study to explore the prevalence and risk factors of renal function progression in post-liver transplantation patients with renal impairment after renal biospy and to understand the the pathology of kidney disease in post-liver transplantation patients with renal impairment.",[25,635],"Renal Insufficiency, Chronic",[27,637,638],"renal biopsy","chronic kidney disease","2025-11-23",{"date":641,"type":34},"2025-11-28",{"date":643,"type":34},"2022-06-01",{"date":212,"type":21},{"name":622,"class":41},{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":77,"phases":655,"briefSummary":656,"conditions":657,"keywords":658,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":42},"100573678","assessment-of-a-quantra-guided-transfusion-algorithm-in-liver-transplantation-100573678","NCT06749405","Assessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation","QUALIVERT","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Patient with ESLD undergoing liver transplantation\n* Individuals affiliated with or beneficiaries of a social security scheme\n* Free and informed written consent obtained in writing from the patient, or where applicable from the trusted person\u002Ffamily member\u002Fclose relative\n\nNon-inclusion Criteria:\n\n* Multi-organ transplantation\n* Congenital haemostasis disorder (such as haemophilia)\n* Patient under juridical protection (persons deprived of liberty or under curatorship or guardianship or safeguard of justice)\n* Pregnant or breast-feeding woman\n* Patient already enrolled in another interventional study with primary or secondary objective of reducing perioperative bleeding or transfusion",{"count":654,"type":21},56,[79],"Liver transplantation carries a substantial risk of bleeding, making precise haemostasis control essential, although assessing coagulation remains challenging. Quantra, a bedside viscoelastic testing device using sonorheometric methods, offers an innovative approach to guiding haemostatic management during surgery. The study aims to determine whether a Quantra-guided transfusion can reduce transfusion and bleeding during liver transplantation when compared to a conventional transfusion approach.",[25],[27,659,660,661,662,663,664,665,666,667],"Bleeding","Blood transfusion","Quantra®","Viscoelastic test","Haemorrhagic surgery","Labile blood products","Randomized controlled trial","Coagulation","End-stage liver disease (ESLD)","2025-09-17",{"date":670,"type":34},"2025-09-22",{"date":672,"type":34},"2025-03-08",{"date":674,"type":21},"2027-03",{"name":676,"class":41},"University Hospital, Toulouse",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":464,"enrollmentInfo":684,"targetDuration":4,"studyType":77,"phases":685,"briefSummary":686,"conditions":687,"keywords":689,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":696,"leadSponsor":698,"locationsCount":42},"100602456","comparison-of-the-postoperative-analgesic-effects-of-itm-and-bi-level-espb-in-liver-transplantation-donors-100602456","NCT07123740","Comparison of the Postoperative Analgesic Effects of ITM and Bi-level ESPB in Liver Transplantation Donors","Comparison of the Postoperative Analgesic Effects of Intrathecal Morphine and Bi-level Erector Spinae Plane Block in Liver Transplantation Donors","Inclusion Criteria:\n\n* Patients aged 18-65 years\n* American Society of Anesthesiologists (ASA) score I-II\n* Body Mass Index (BMI) between 18-30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Patients under 18 and over 65 years of age\n* ASA score III and above\n* Patients with a history of bleeding diathesis\n* BMI below 18 or above 30 kg\u002Fm2",{"count":250,"type":21},[79],"Liver transplantation is a life-saving procedure for patients with end-stage liver disease, and postoperative pain management is critical for optimizing donor recovery and overall outcomes. Poorly controlled pain following donor hepatectomy may reduce quality of life, delay mobilization, and contribute to the development of chronic pain syndromes.\n\nRegional anesthesia techniques, such as intrathecal morphine and erector spinae plane block, have been utilized to enhance postoperative analgesia and reduce perioperative opioid requirements, potentially minimizing opioid-related adverse effects.\n\nIn this study, we aimed to compare the postoperative analgesic efficacy of intrathecal morphine and Bi-level erector spinae plane block in living liver donors.",[25,688],"Pain Management",[25,690,691],"Intrathecal Morphine","Erector Spinae Plane Block","2025-08-18",{"date":694,"type":34},"2025-08-19",{"date":692,"type":34},{"date":697,"type":21},"2026-07-24",{"name":699,"class":548},"Ankara Etlik City Hospital"]