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

Sponsored by Rennes University Hospital

About this trial

Last updated 10 months ago

Study ID

35RC22_9768_TRANSPERF

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started 6 months ago

What is this trial about?

Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in France, 12.9% of patients on the waitlist either died or were delisted for worsening of their condition. However a substantial number of perfectly viable organs are wrongly discarded based on a highly subjective assessment as the level of acceptance varies widely depending on the physician's judgement. The idea of using Normothermic Machine Perfusion (NMP) not only to preserve the liver graft but also for selection purposes is a concept that has been already investigated. A few trials have analyzed the value of normothermic perfusion to assess rejected liver grafts. Several teams demonstrated that NMP provides a tool to assess organ viability pre-transplantation as the liver is able to maintain an almost physiological metabolism. These preliminary results came from small samples, 45% of which originated from donation after circulatory death (DCD). They need confirmation in a larger sample of organs from donors with brainstem death (DBD), adapted to the French liver allocation system. This trial will reproduce and confirm the results of the previous studies in order to establish viability testing as the de facto method for high-risk or rejected grafts. It will also validate existing viability markers so as to define a new standard for viability testing using NMP.

What are the participation requirements?

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

Exclusion Criteria