TRANSPERFNormothermic Oxygenated Perfusion for Assessing Discarded Liver Viability
NMP viability testing
Digestive System Diseases
+ Liver Diseases
Other Study
Summary
Study start date: December 15, 2025
Actual date on which the first participant was enrolled.This study is focused on improving the assessment of donor livers that are often discarded despite being potentially healthy enough for transplantation. Liver transplantation is a crucial treatment for severe liver diseases, but there is a shortage of available livers. Many livers are turned down based on subjective assessments or donor characteristics, leading to viable organs being wasted. The study uses a process called Normothermic Machine Perfusion (NMP) to evaluate if these discarded livers can be deemed suitable for transplantation. This method could increase the number of usable organs and improve outcomes for patients waiting for a liver transplant. Participants in this study involve livers that have been initially discarded based on current assessment standards. The OrganOx metra device is used to perfuse these livers with blood and nutrients at normal body temperature, providing an environment similar to that of a living body. This process helps to objectively assess the liver's viability by evaluating various functions such as lactate clearance and bile production. The study measures how many of these livers become usable for transplantation and how well they function three months after the procedure. Successful outcomes could lead to more reliable criteria for liver viability, reducing the risk of transplant failure and saving more lives.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.99 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA : FOR LIVER DONORS * Donation after brainstem death (DBD) * Liver graft refused by 5 different transplant centres and after rescue allocation ("hors tour") FOR LIVER TRANSPLANT RECIPIENTS * ≥ 18 years old * Candidates for a first elective liver transplantation (patients with a pre-transplant work-up excluding: re-transplantation, emergency transplantation (e.g. fulminant hepatitis), multi-organ or heterotopic transplantation) * UNOS status IV (non-ventilated, no vasopressor support) * Absence of renal insufficiency defined as a GFR of less than 60 mL/min/1.73 m² for three months or more * MELD Score ≤ 25 * Willing and able to attend follow-up examinations * Having signed an informed consent document NON-INCLUSION CRITERIA: FOR LIVER DONORS * Macroscopic features of advanced fibrosis or cirrhosis at procurement * Transplantation using a split graft, in situ or ex situ * Estimated cold ischemic time greater than 8 hours (5 hours maximum of graft transport in cold ischemia) FOR LIVER TRANSPLANT RECIPIENTS * Mentally or legally incapacitated * Transplantation for fulminant hepatic failure * Early or late re-transplantation * Combined liver transplant with any other organ, en-bloc or not * Heterotopic liver transplantation
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Hôpital Croix Rousse
Lyon, FranceCHU de Montpellier
Montpellier, FranceCHU de Rennes PONTCHAILLOU
Rennes, France