[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622405":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":10,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Living liver donors and recipients",null,"The study population consists of living liver donors and their corresponding recipients recorded in the International LDLT registry.",[13],"Procedure: Living donor liver transplantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Living donor liver transplantation","Donors who underwent living donor hepatectomy and recipients who underwent living donor liver transplantation.",[9],[21,22],"Live donor liver transplantation","Living donor hepatectomy",[24],{"name":25,"affiliation":5,"role":26},"Robert C. Minnee, MD, PhD, MSc","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Hayo W. ter Burg, MD, MSc","CONTACT","+316 83233210","h.terburg@erasmusmc.nl",[34],{"facility":5,"status":10,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],4.47917,51.9225,{"lat":44,"lon":43},[47],{"name":48,"role":30,"phone":31,"phoneExt":10,"email":32},"Hayo W. ter Burg, MD",{"type":26,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Robert Minnee","Principal Investigator, Hepato-Pancreato-Biliary\u002FTransplant Surgeon, Epidemiologist","100622405","prediction-models-for-ldlt-outcomes-100622405",false,"NCT07383194","Prediction Models for LDLT Outcomes","A Clinically Applicable Prediction Model for Living Donor Liver Transplantation Outcomes Using the International LDLT Registry","PREDICTLDLT","Inclusion Criteria:\n\n\\- All LDLT donor-recipient pairs registered in the International LDLT Registry from September 1, 2023 to present.\n\nExclusion Criteria:\n\n* Two stage LDLT\n* Dual grafts LDLT","ALL",{"count":62,"type":63},3000,"ESTIMATED","OBSERVATIONAL","Rationale:\n\nLiving donor liver transplantation (LDLT) has emerged as an important option for patients with end-stage liver disease. To facilitate international and meaningful comparisons, our institution participates in the International LDLT Registry. Several models to predict outcomes post-LDLT have been developed to council and justify the major surgery that the living liver donors undergo. However, most proposed models are at high risk of bias and demonstrate suboptimal discriminative ability.\n\nThis study aims to externally validate the most promising prediction models and subsequently, develop a new, clinically applicable prediction model for LDLT outcomes, using the International LDLT Registry.\n\nObjective(s):\n\nThe main objective of this study is to develop a new, clinically applicable prediction model for LDLT outcomes, using the International LDLT Registry.\n\nThe secondary objective is to externally validate the most promising existing prediction models for LDLT outcomes, using the International LDLT Registry.\n\nStudy type:\n\nThis is an observational, multicenter cohort study using prospectively collected data from the International LDLT Registry. Registry data will be analyzed retrospectively for the purposes of external model validation and prediction model development.\n\nStudy population:\n\nThe study population consists of living liver donors and their corresponding recipients recorded in the International LDLT registry.\n\nMethods:\n\nFor external validation, parameters will be entered in the existing prediction models resulting in the predicted risks. Model discrimination will be measured using the area under the curve (AUC) and by the discrimination slope. The DeLong test will be used to test for difference between the AUC of the different prediction models. Calibration will be evaluated by comparing the observed with the predicted rate of events and graphically represented by calibration plots.\n\nFor the development of a new prediction model, the outcome of interest is early graft failure, defined as graft loss within 90 days after transplantation. A multivariable logistic regression model will be developed to estimate the individual risk of early graft failure. Internal validation will be performed using bootstrapping, and model performance will be assessed in terms of discrimination and calibration. Model performance will also be tested in subgroups.",[67],"Living Donor Liver Transplantation",[69,70,71,72,73],"Liver Transplantation","Living Donor","Graft Survival","Mortality","Prediction Algorithms","NOT_YET_RECRUITING","2026-02-02",{"date":77,"type":78},"2026-02-03","ACTUAL",{"date":80,"type":63},"2026-03-10",{"date":82,"type":63},"2027-07-02",{"name":5,"class":6},1]