Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers

Launched by RENNES UNIVERSITY HOSPITAL · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new method called Normothermic Machine Perfusion (NMP) to see if it can help determine whether discarded livers are still viable for transplantation. Many livers that could potentially save lives are often turned down for transplant because of subjective assessments by doctors. The goal of this trial is to confirm that NMP can accurately assess the health of these livers, especially those that have been previously rejected, and to establish new standards for evaluating liver viability before transplantation.

To be eligible for this trial, liver donors must have been declared brain dead and their livers must have been refused by five different transplant centers. For patients looking to receive a liver transplant, they should be at least 18 years old, not in emergency situations, and have certain health conditions that make them suitable for a first-time liver transplant. Participants will undergo follow-up examinations and must agree to be part of the study by signing a consent form. This trial is important because it aims to improve the chances of getting suitable livers for transplant, ultimately helping more patients in need.

Gender

ALL

Eligibility 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