Recruiting soon

TRANSPERFNormothermic Oxygenated Perfusion for Assessing Discarded Liver Viability

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What is being tested

NMP viability testing

Other
Who is being recruted

Digestive System Diseases

+ Liver Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Phase 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorRennes University Hospital
Study ContactHeithem JEDDOU, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleNormothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers. An Open Label, Non-randomized, Prospective, Single Arm Trial
NCT06950398
Principal SponsorRennes University Hospital
Study ContactHeithem JEDDOU, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

99 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Digestive System DiseasesLiver Diseases

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study 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

Suspended

APHP_Hôpital Beaujon

Clichy, FranceOpen APHP_Hôpital Beaujon in Google Maps
Suspended

Hôpital Croix Rousse

Lyon, France
Suspended

CHU de Montpellier

Montpellier, France
Suspended

CHU de Rennes PONTCHAILLOU

Rennes, France
Recruiting soon6 Study Centers