[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638137":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":41,"locations":49,"responsibleParty":69,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":100,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypothermic Machine Perfusion","EXPERIMENTAL","Liver grafts are preserved using hypothermic machine perfusion prior to transplantation. Following procurement and an initial period of static cold storage, grafts undergo ex situ hypothermic oxygenated perfusion under controlled conditions before implantation.",[13],"Device: Hypothermic Machine Perfusion",{"label":15,"type":16,"description":17,"interventionNames":18},"Static Cold Storage","ACTIVE_COMPARATOR","Liver grafts are preserved using conventional static cold storage according to standard institutional protocols. Following procurement, grafts are maintained under hypothermic conditions without active perfusion or oxygenation until implantation.",[19],"Procedure: Static Cold Storage",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Hypothermic machine perfusion of the liver graft is performed prior to transplantation using an ex situ perfusion system under controlled conditions, in which an oxygenated perfusate is circulated through the liver graft vasculature.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"PROCEDURE","Liver graft preservation using conventional static cold storage under hypothermic conditions until transplantation.",[15],[31,35,38],{"name":32,"affiliation":33,"role":34},"Wellington Andraus, MD, PhD","Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":33,"role":37},"Rubens Macedo Junior, MD, PhD","STUDY_CHAIR",{"name":39,"affiliation":33,"role":40},"Alexandre Santana, PhD","STUDY_DIRECTOR",[42,46],{"name":32,"role":43,"phone":44,"phoneExt":25,"email":45},"CONTACT","+5511982118909","wellington@usp.br",{"name":39,"role":43,"phone":47,"phoneExt":25,"email":48},"+5511931002779","alesantana@usp.br",[50],{"facility":33,"status":25,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"São Paulo","05403-000","Brazil","BR",{"type":56,"coordinates":57},"Point",[58,59],-46.63611,-23.5475,{"lat":59,"lon":58},[62,63,64,65,68],{"name":32,"role":43,"phone":44,"phoneExt":25,"email":45},{"name":39,"role":43,"phone":47,"phoneExt":25,"email":48},{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"name":66,"role":67,"phone":25,"phoneExt":25,"email":25},"Rubens Junior, MD, PhD","SUB_INVESTIGATOR",{"name":39,"role":67,"phone":25,"phoneExt":25,"email":25},{"type":70,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[72],{"name":73,"class":74},"XVIVO Perfusion","INDUSTRY","100638137","hypothermic-machine-perfusion-for-liver-graft-preservation-100638137",false,"NCT07595627","Hypothermic Machine Perfusion for Liver Graft Preservation","Prospective and Randomized Clinical Study of the Effect of Hypothermic Machine Perfusion on Liver Graft Preservation","HOPE-Liver","Donor-related inclusion criteria:\n\n* Liver donors with confirmed diagnosis of brain death.\n* Extended criteria donors (ECD).\n* Age ≥18 years.\n* Family consent for organ donation obtained.\n* Negative serology for HTLV, HIV, Chagas disease, and hepatitis B and C.\n\nRecipient-related inclusion criteria:\n\n* Adult patients (≥18 years) undergoing liver transplantation.\n* Diagnosis of end-stage liver disease or indication for liver transplantation.\n* Candidates for primary liver transplantation.\n* Ability to understand and provide written informed consen\n\nDonor-related exclusion criteria:\n\n* Presence of moderate or severe hepatic steatosis.\n* Pediatric donors.\n* Donors classified as ideal, defined by the simultaneous presence of all of the following criteria: Age \\\u003C35 years, Body mass index (BMI) \\\u003C28 kg\u002Fm², No history of cardiopulmonary resuscitation, Norepinephrine requirement \\\u003C0.5 µg\u002Fkg\u002Fmin, Liver enzymes (AST or ALT) ≥2 times the upper limit of normal, Intensive care unit stay ≤7 days\n\nRecipient-related exclusion criteria:\n\n* Complex portal vein thrombosis (grade III or IV).\n* Combined or dual organ transplantation.\n* Retransplantation.\n* Acute liver failure.\n* MELD score \\>30.\n* History of multiple prior liver or biliary surgeries.","ALL","18 Years",{"count":86,"type":87},40,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this clinical trial is to evaluate whether hypothermic machine perfusion improves liver graft preservation and post-transplant outcomes compared to conventional static cold storage in adult patients undergoing liver transplantation. This study focuses on liver grafts from deceased donors, including those with extended criteria, which are more susceptible to ischemia-reperfusion injury and early graft dysfunction.\n\nThe main questions it aims to answer are:\n\nDoes hypothermic machine perfusion reduce ischemia-reperfusion injury and improve early graft function after liver transplantation? Does this preservation strategy improve clinical outcomes, including graft survival, complication rates, and post-transplant recovery, compared to static cold storage?\n\nResearchers will compare hypothermic machine perfusion (ex situ, oxygenated perfusion at low temperature) to standard static cold storage to assess differences in graft preservation quality and post-transplant outcomes.\n\nParticipants will:\n\nReceive a liver graft preserved either by hypothermic machine perfusion or static cold storage, according to a 1:1 randomization protocol Undergo standard liver transplantation procedures Be followed after transplantation with clinical, laboratory, imaging, and biomarker assessments at predefined time points (7 days, 30 days, 6 months, and 1 year)\n\nAdditional evaluations will include biochemical markers of liver function, inflammatory and immunological mediators, mitochondrial function assessment, and histological analysis to better characterize graft injury and recovery.",[93,94],"Liver Transplant","Liver Failure",[9,96,97,98,99],"Liver Transplantation","Ischemia-Reperfusion Injury","Ex Vivo Liver Perfusion","Extended Criteria Donors","NOT_YET_RECRUITING","2026-05-14",{"date":103,"type":104},"2026-05-19","ACTUAL",{"date":106,"type":87},"2026-05-07",{"date":108,"type":87},"2028-05-07",{"name":5,"class":6},1]