[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610692":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":31,"responsibleParty":42,"collaborators":44,"id":57,"slug":31,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":31,"enrollmentInfo":65,"targetDuration":31,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":79,"whyStopped":31,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":31},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Xo Port Organ Preservation System","EXPERIMENTAL","Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage",[13],"Device: Xo Port Organ Preservation System",{"label":15,"type":16,"description":17,"interventionNames":18},"Static Ice Storage","ACTIVE_COMPARATOR","Traferox Transport System containing ice-packs as used for conventional cold static storage",[19],"Device: Standard of Care - Ice packs",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","It is a disposable temperature-controlled hypothermic transportation system that maintains the donated heart temperature between 8 and 12°C. It consists of an insulated chamber; eutectic gel packs containing a specialized phase change material (composition under manufacturer's patent) preconditioned before use (by freezing in a 4°C temperature-regulated refrigerator for 48 hours), which maintain temperature between 8 and 12°C through passive cooling; a removable insert, a cradle to hold the organ bag, an internal temperature probe; a logger for continuous monitoring and maintenance of temperature over an extended period of time, an internal venting system that allows air circulation to ensure homogenous temperature for a validated maximal time of 24 hours; and casters and a telescopic handle to facilitate transport.",[9],[26],"Traferox Transport System",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard of Care - Ice packs","Cold static donor heart preservation is currently the mainstay of organ transportation after procurement. The donor heart is placed in the Traferox Transport system with ice-packs.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Yasbanoo Moayedi, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Judy Sleek, BSc.","CONTACT","437-676-2974","judy.sleek@uhn.ca",{"type":43,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[45,48,50,52,54],{"name":46,"class":47},"CareDx","INDUSTRY",{"name":49,"class":6},"Montreal Heart Institute",{"name":51,"class":6},"London Health Sciences Centre",{"name":53,"class":6},"Ottawa Heart Institute Research Corporation",{"name":55,"class":56},"Traferox Technology Inc.","UNKNOWN","100610692",false,"NCT07230886","Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction","PROTECT-PGD","Inclusion Criteria:\n\n* Recipient: Adult (\\>17 years old)\n* Donor: Donation after brain death acceptable for transplant as determined by a procuring physician unaware of randomization sequence at the time of acceptance\n\nExclusion Criteria:\n\n* Recipient: Multi-organ transplant recipients; Participating in an interventional study.\n* Donor: Donation after cardiac death; Use of organ care system","ALL","17 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to test the feasibility of the study protocol comparing a novel temperature control system - Xo Port Organ Preservation System - to static ice for heat preservation for Heart Transplant. The main questions of the study are as follows:\n\nDoes the Incidence of severe PGD change within the first 24 hours of heart transplant in patients randomized to the Xo Port Organ Preservation System?\n\nWas there a change in composite efficacy endpoints in participants randomized to the Xo Port Organ Preservation System compared to static ice storage?\n\nWere the feasibility outcomes achieved?\n\nWere there any protocol deviations?\n\nParticipants will:\n\nBe randomized to either the Xo Port Organ Preservation System or static ice storage.\n\nComplete a questionnaire at the time of screening, day 0, 7, and 90 days post transplant.\n\nHave blood drawn - with their standard of care blood draws - after their transplant, the day after, and 7 days post transplant.",[73],"Primary Graft Dysfunction",[73,75,76,77,78],"Transplant","Traferox","Preservation Therapy","X Port Preservation System","NOT_YET_RECRUITING","2025-11-13",{"date":82,"type":83},"2025-11-17","ACTUAL",{"date":85,"type":67},"2025-11",{"date":87,"type":67},"2028-12",{"name":5,"class":6}]