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

NCT06950398 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 35RC22_9768_TRANSPERF
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Organ Transplantation; Liver Dysfunction; Liver Diseases

Keywords

Liver Transplantation; Normothermic oxygenated perfusion; NMP; Discarded livers; Viability assessment

Outcome Measures

Primary Outcomes (2)

• - To assess the efficacy of NMP to provide objective assessment of the viability of livers which were initially discarded

  \- Rate of initially discarded livers eventually transplanted after viability testing using NMP (A stopping rule will be implemented based on the incidence of initially discarded livers eventually transplanted. NMP would be considered as: * uninteresting if the rate of discarded livers finally rescued is ≤ 25% * and promising if ≥ 40%.)

  Day 0

• - To assess grafts survival of rescued livers after transplantation

  \- Rate of functional grafts

  Month 3, among transplanted rescued livers

Secondary Outcomes (13)

• - To assess early graft dysfunction

  Day 7

• - To assess primary non-function

  Day 7

• - To assess intraoperative morbidity

  Day 0

• - To assess postoperative morbidity

  Month 3

• - To assess infectious complications

  Month 3

Study Arms (1)

Normothermic oxygenated perfusion (NMP) viability testing

EXPERIMENTAL

Discarded liver grafts are connected to a normothermic perfusion machine (OrganOx Metra®) for a period of 4 to 12 hours prior to transplantation, to assess their viability.

Other: NMP viability testing

Interventions

NMP viability testing OTHER

NMP viability testing before transplantation of discarded livers

Normothermic oxygenated perfusion (NMP) viability testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (6)

APHP_Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Croix Rousse

Lyon, 69003, France

Location

CHU de Montpellier

Montpellier, 34090, France

Location

CHU de Rennes PONTCHAILLOU

Rennes, 35000, France

Location

CHRU Tours

Tours, 37170, France

Location

APHP_Hopital Paul Brousse

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Heithem JEDDOU, MD

CONTACT

+0033299289841; Heithem.JEDDOU@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: National, multicenter, exploratory open-label, prospective, non-randomized, single-arm trial

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: April 30, 2025
• Study Start: December 15, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): June 15, 2029
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)