[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544671":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":76,"collaborators":78,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":28,"enrollmentInfo":90,"targetDuration":28,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":28,"overallStatus":46,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Static Cold Storage","ACTIVE_COMPARATOR","The donor liver will be flushed in situ with 4C UW preservation solution (or HTK) through the aorta and portal vein, retrieved, and transported to the transplant centre in an icebox.",[13],"Device: Machine Perfusion",{"label":15,"type":10,"description":16,"interventionNames":17},"Normothermic Regional Perfusion","The donor aorta and inferior cava vein will be cannulated, followed by descending thoracic aorta cross-clamp and initiation of perfusion (Cardiohelp device) with the donor's own blood at 37C for 2h (while monitoring pump flow, venous O2 saturation, lactate and ALT), followed by in-situ flush with 4C preservation solution as in SCS arm.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Hypothermic oxygenated perfusion","The liver will be retrieved and preserved as in SCS arm. Then, on arrival to the transplant unit, the portal vein and hepatic artery will be cannulated, and the liver perfused with hypothermic oxygenated solution (VitaSmart device) for 2h.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Machine Perfusion","The quality of DCD organs can be improved by replacing the icebox (static cold storage or SCS), which remains the main approach to preserve the livers after having been retrieved, by strategies that perfuse the livers in a machine (machine perfusion or MP). There are currently 3 MP strategies employed in the clinic: normothermic regional perfusion (NRP) is used in the donors by perfusing the liver with the donor's blood at 37 degrees Celsius, and normothermic (NMP) or hypothermic (HOPE) perfusion are used in the procured livers out of the body (using warm or cold perfusion fluids, respectively). To date, no controlled objective comparisons of these different MP strategies have been undertaken and the doctors do not have a good understanding of their mechanisms of action.",[19,15,9],null,[30],{"name":31,"affiliation":32,"role":33},"Alberto Sanchez-Fueyo","King's College London","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":28,"email":38},"CONTACT","02078485883","sanchez_fueyo@kcl.ac.uk",{"name":40,"role":36,"phone":41,"phoneExt":28,"email":42},"Jurate Wall","07961780517","jurate.wall@kcl.ac.uk",[44,62],{"facility":45,"status":46,"city":47,"state":28,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospitals Birmingham NHS Foundation Trust","RECRUITING","Birmingham","B15 2GW","United Kingdom","UK",{"type":52,"coordinates":53},"Point",[54,55],-1.89983,52.48142,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":28,"email":61},"Bobby Dasari","44121 627 2000","Bobby.Dasari@uhb.nhs.uk",{"facility":63,"status":46,"city":64,"state":28,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Royal Free London NHS Foundation Trust","London","NW3 2QG",{"type":52,"coordinates":67},[68,69],-0.12574,51.50853,{"lat":69,"lon":68},[72],{"name":73,"role":36,"phone":74,"phoneExt":28,"email":75},"Carlo Ceresa","4420 7794 0500","carlo.ceresa1@nhs.net",{"type":77,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[79],{"name":32,"class":6},"100544671","immunometabolism-of-machine-perfusion-strategies-100544671",false,"NCT06371924","Immunometabolism of Machine Perfusion Strategies","Mechanistic Evaluation of Machine Perfusion Strategies in Donation After Circulatory Death Liver Transplantation","iMaps","Inclusion Criteria Donor inclusion criteria\n\n1. DCD category III donors considered for abdominal organs-only retrieval.\n2. Donor age ≥18 years.\n3. Retrieval procedure allocated to KCH or UHB NORS teams.\n4. Donor liver accepted for a patient at KCH or UHB transplant waiting list via the standard offering process.\n5. Functional donor warm ischaemia (defined as a period between the systolic blood pressure \\\u003C50mmHg and aortic cold flush) ≤30 minutes.\n6. Donor BMI \\\u003C35kg\u002Fm2.\n7. Predicted cold ischaemic time \\\u003C8 hours.\n8. Donor family has given consent to use donated liver for research.\n\nTransplant recipient inclusion criteria\n\n1. Recipients 18 years of age or older.\n2. Listed on an elective transplant waiting list.\n3. First liver transplantation.\n4. Suitable to receive a DCD graft based on the liver listing MDT.\n5. Willingness to consent for the study participation.\n\nExclusion Criteria Donor exclusion criteria\n\n1. Donor is HIV, hepatitis B (HBV HbsAg) or hepatitis C (HCV RNA) positive. HBV anti-Hbc positive donors are acceptable.\n2. Macroscopic evidence of fibrosis.\n3. Liver weight \\>2.5 kg.\n4. Retrieval of cardiothoracic organs intended for transplantation.\n5. Any medical condition that, in the opinion of the principal investigator, would interfere with safe completion of the trial.\n\nTransplant recipient exclusion criteria\n\n1. High-risk surgical candidates (i.e. presence of extensive portomesenteric thrombosis, previous complex upper abdominal surgery).\n2. Patients receiving super-urgent transplantation for acute and acute-on-chronic liver failure.\n3. Patients unable to give full informed consent.","ALL","18 Years",{"count":91,"type":92},36,"ESTIMATED","INTERVENTIONAL",[95],"NA","There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI).\n\nThe discarded organs are mostly those coming from donors who have died due to cardiac arrest (called 'donation after circulatory death' or DCD), with only 27% of them being used in the UK. The quality of these DCD organs could be improved by changing how they are preserved after being removed from the donor. The most commonly used strategy is still to remove the livers and put them in an icebox ('static cold storage' or SCS). The alternative approaches, which are more complex and expensive, but that can also improve the quality of the DCD livers, involve using machines to pump fluids through the livers ('machine perfusion' or MP).\n\nThere are three MP methods being used in patients: 1) normothermic regional perfusion (NRP), which involves pumping the donor's blood through the liver after the donor has died but the liver is still in the donor's body; 2) normothermic machine perfusion (NMP), in which the liver is pumped with blood outside of the donor's body; and 3) hypothermic machine perfusion (HOPE), which is also used outside of the donor's body by pumping cold fluid into the liver. HOPE and NRP have been shown to improve how well DCD livers function after transplantation. NMP can also improve the quality of the DCD livers, but its main advantage is that it allows confirming that the donated liver functions well before proceeding with the transplant. Until now, there has not been a proper comparison of these methods, and the doctors do not understand well the mechanisms through which MP improves the quality of the DCD livers.\n\nThe iInvestigators plan to conduct a study where 36 DCD human livers will be split into three groups: SCS, NRP, and HOPE. After that, they will be put in NMP to confirm that they are good enough to be transplanted and to study the mechanisms through which NRP, SCS and HOPE work.",[98],"Liver Transplantation","2025-08-08",{"date":101,"type":102},"2025-08-13","ACTUAL",{"date":104,"type":102},"2025-02-17",{"date":106,"type":92},"2026-05-31",{"name":5,"class":6},2]