[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"end-stage-liver-disease-esld\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:end-stage-liver-disease-esld":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,82],{"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":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100640555","establishing-a-reference-framework-for-outcomes-after-machine-preserved-liver-transplantation-in-europe-100640555",false,"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","ALL","18 Years",{"count":20,"type":21},10000,"ESTIMATED","OBSERVATIONAL","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.",[25,26,27,28],"End-stage Liver Disease (ESLD)","Acute Liver Failure","Liver Cirrhosis","Liver Transplantation",[30,31,32,33,34,35,36],"machine perfusion","liver transplantation","hypothermic machine perfusion","normothermic machine perfusion","normothermic regional perfusion","organ preservation","machine preservation","RECRUITING","2026-07-30",{"date":40,"type":41},"2026-08-03","ACTUAL",{"date":43,"type":41},"2026-04-21",{"date":45,"type":21},"2030-12-31",{"name":47,"class":48},"University Medical Center Groningen","OTHER",9,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100646057","restrictive-fluid-management-in-liver-transplantation-refil-100646057","NCT07695363","Restrictive Fluid Management In Liver Transplantation (REFIL)","Effects of an Intraoperative Low-splanchnic Blood Volume Restrictive Fluid Management Strategy Compared to a Cardiac Output Optimized Liberal Fluid Management Strategy on Postoperative Outcomes in Liver Transplantation: A Multicenter Randomized Controlled Trial (REFIL-2)","REFIL-2","Inclusion Criteria:\n\n1. Adult ≥ 18 years old\n2. Undergoing liver transplantation (LT)\n3. End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.\n\nExclusion Criteria:\n\n1. Undergoing LT for an indication other than ESLD (e.g., acute liver failure, primary liver cancer without ESLD, retransplantation, amyloid neuropathy, polycystic liver disease, or any other indication not associated with ESLD)\n2. Undergoing combined solid organ transplantations\n3. Any of the following conditions:\n\n   * severe chronic renal failure (GFR \\\u003C 15 ml\u002Fminute\u002F1.73 m2 \\[CKD-EPI equation\\] or already on renal replacement therapy (RRT))\n   * severe anemia (hemoglobin level \\\u003C 80 g\u002FL)\n   * hemodynamic instability (norepinephrine equivalent \\> 10 ug\u002Fmin)\n4. Physician refusal to enroll the patient.",{"count":59,"type":21},866,"INTERVENTIONAL",[62],"NA","The goal of the REFIL-2 study is to evaluate the effectiveness of a low splanchnic blood volume restrictive fluid management strategy (a strategy that involves limiting fluid administration and prioritizing the use of medications that raise blood pressure during surgery, combined with phlebotomy) in improving patients' recovery after surgery. The study compares the low splanchnic blood volume restrictive fluid management strategy to an optimized cardiac-output liberal fluid management strategy (which involves administering more fluids to raise blood pressure with less reliance on medications). Outcomes important to patients will be measured.\n\nThis study (REFIL-2) had a vanguard phase (internal pilot) that included 138 patients (NCT05647733). The patients included in the vanguard pilot phase were not compared between groups but only analyzed descriptively using aggregated data. Only feasibility metrics were compared (see NCT05647733). These 138 patients were thus rolled into the REFIL-2 trial and included in the final sample size reported herein.",[65,25],"Liver Transplantation (LT)",[28,67,68,69,70,71],"Phlebotomy","Hemodynamic Management","Fluid Management","Transfusions","Liver Diseases","2026-07-08",{"date":74,"type":41},"2026-07-10",{"date":76,"type":41},"2026-02-15",{"date":78,"type":21},"2031-11",{"name":80,"class":48},"Centre hospitalier de l'Université de Montréal (CHUM)",4,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":60,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"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":91,"type":21},1546,[62],"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.",[28,95,25],"Tranexamic Acid",[28,97],"tranexamic acid","2025-12-02",{"date":100,"type":41},"2025-12-08",{"date":102,"type":41},"2025-11-01",{"date":104,"type":21},"2027-12-01",{"name":106,"class":48},"RenJi Hospital",1]