Developing Prediction Models for Allograft Failure After Liver Transplantation

Status unconfirmed

Conditions studied: Liver Transplant Disorder

In brief

Prompt identification of allograft failure (AF) is highly desirable to address patients to liver retransplantation, in order to maximize results and preserve patients safety. Recently, sophisticated kinetic models became available, offering the possibility to predict 90-day AF with unprecedented accuracy, by computing data from the first 10 days after liver transplant (LT). The growing utilization of extended criteria and cardiac death donors stimulates the transplant community to further refine such predictive models and validate them on a larger scale population of patients across the nations. This study aims to develop new algorithms for the timely prediction of AF at 90 and 365 days using a prospective international cohort from high-volume centers, to validate them on a large retrospective cohort, to identify the best time for retransplantation, to stratify the risk of AF according to the graft type (i.e. DBD, ECD, DCD, LD), to weigh the effect of risk-mitigation strategies, and to assess the correlation with post-LT morbidity and mortality.

Key facts

Study ID

NCT05289609

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

5000

Starts

2022-04-01

Expected to finish

2024-04-01

Last updated by the study team

2022-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult recipients (≥18 years)
• First transplant (retransplant cases should be enrolled if the first transplant is part of the study)
• DBD grafts
• DCD grafts (controlled and uncontrolled)
• DBD and DCD grafts managed by perfusion machines
• Living donor grafts (both left lobe and right lobe grafts) transplanted into adult recipients.
• Split liver grafts (both left lobe and right lobe grafts) transplanted into adult recipients.

You may not qualify if…

• Combined grafts (e.g., liver-kidney, liver-heart, liver-pancreas, multi-visceral grafts)
• Domino grafts
• Heterotopic grafts
• Double grafts
• Recipients undergoing liver transplants for cholangiocarcinoma and colorectal liver metastases

Where it is running

• Transplantation Center, Digestive Disease and Surgery Institute, Cleveland Clinic — Cleveland, Ohio, United States
• Division of Hepato Pancreatic Biliary Surgery and Liver Transplant Unit, Department of General Surgery, Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• Dumont-UCLA Transplant and Liver Cancer Centers, Department of Surgery, David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Department of Transplant, Mayo Clinic Florida — Jacksonville, Florida, United States
• Division of Organ Transplantation, Department of Surgery, University of Massachusetts Memorial Hospital, University of Massachusetts — Worcester, Massachusetts, United States
• Liver Transplant Division, Santa Isabel Hospital — Blumenau, Brazil
• Multi-Organ Transplant and HPB Surgical Oncology, Division of General Surgery, University Health Network — Toronto, Canada
• First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, China
• Dr Rela Institute and Medical Centre — Chennai, India
• Department of Surgery, Oncology and Gastroenterology, Padova University Hospital — Padova, Italy
• Department of Surgery, Oncology and Gastroenterology, Padova University Hospital — Padova, Italy
• General Surgery and Organ Transplantation Unit, Sapienza University of Rome — Roma, Italy
• Fondazione Policlinico Universitario A. Gemelli, IRCCS — Roma, Italy
• GSTeP - Gemelli Science and Technology Park, Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy
• Department of Surgery, Tokyo Women's Medical University — Shinjuku-Ku, Japan
• Erasmus MC Transplant Institute, University Medical Center Rotterdam, Department of Surgery, Division of Hepato-Pancreato-Biliary and Transplant Surgery — Rotterdam, Netherlands
• Cirugia General y del A. Digestivo, Hospital Universitario La Paz — Madrid, Spain
• Department of Transplant Surgery, Edinburgh Transplant Centre, Royal Infirmary of Edinburgh — Edinburgh, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.