[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583503":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":54,"collaborators":19,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":19,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":19,"enrollmentInfo":65,"targetDuration":19,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Delayed implantation with ex vivo machine perfusion of kidney allograft.","EXPERIMENTAL","Patients presenting for heart\u002Fkidney transplantation who consent to participate will be enrolled in this prospective, open-label, single-arm trial to undergo heart transplantation with planned delayed kidney transplantation with machine perfusion of the kidney allograft. Kidneys will be preserved using hypothermic oxygenated machine perfusion (HOPE) prior to transplantation. Timing of kidney implantation will be determined by recipient stability (e.g., vasopressor and inotrope requirements, coagulopathy, heart graft function) and allow for at least 6 hours of HOPE preservation. Both heart and kidney transplant procedures will follow standard of care techniques.",[13],"Other: Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.","During combined heart and kidney transplantation, heart and kidney allografts may be implanted during a single operative event, or with delayed kidney implantation in a second operative event. Timing of the delay is often determined by recipient stability and kidney availability; however, clinicians must balance recipient factors with accumulating cold ischemic time of the kidney allograft. This study uses hypothermic oxygenated machine perfusion to reduce ischemic injury to the kidney allograft and allow for improved recipient stability with planned delayed implantation of the kidney graft. Delays will allow for at least 6 hours of hypothermic oxygenated machine perfusion prior to implantation.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Justin A Steggerda, M.D.","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","310-423-3276","justin.steggerda@cshs.org",{"name":30,"role":26,"phone":19,"phoneExt":19,"email":31},"Noriko Ammerman, Pharm.D.","noriko.ammerman@cshs.org",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Los Angeles","California","90048","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-118.24368,34.05223,{"lat":44,"lon":43},[47,48,49,52],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"name":50,"role":51,"phone":19,"phoneExt":19,"email":19},"Tyler Gunn, M.D.","SUB_INVESTIGATOR",{"name":53,"role":51,"phone":19,"phoneExt":19,"email":19},"Steven A Wisel, M.D.",{"type":23,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Justin Steggerda","Assistant Professor of Surgery, Division of Abdominal Transplant Surgery","100583503","staged-kidney-transplantation-during-combined-heartkidney-transplantation-100583503",false,"NCT06877169","Staged Kidney Transplantation During Combined Heart\u002FKidney Transplantation","Inclusion Criteria:\n\n* Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.\n\nExclusion Criteria:\n\n* Patients who undergo simultaneous heart\u002Fkidney transplantation in a single operative event due to medical necessity will be excluded.\n* Patients with medical records flagged as \"break-the-glass\" or \"research opt-out\" within the center's electronic health record.","ALL","18 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"NA","The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart\u002Fkidney transplantation.",[73,74,75],"Heart Failure","Chronic Kidney Disease","End-stage Kidney Disease",[77,78,79,80],"combined heart and kidney transplant","simultaneous heart and kidney transplant","hypothermic oxygenated machine perfusion","organ preservation","2025-05-29",{"date":83,"type":84},"2025-06-03","ACTUAL",{"date":86,"type":84},"2025-04-07",{"date":88,"type":67},"2035-02-28",{"name":5,"class":6},1]