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Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time

NCT06874296 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-04-15

No results posted yet for this study

Summary

The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. This process keeps a donated liver working outside the body before transplantation, allowing surgeons to assess whether livers previously considered unsuitable can still be used.

The main questions this study aims to answer are:

* Does this method help patients get a transplant sooner?
* Can this method make more livers available for transplant?
* Does it improve survival and health after transplant?

Participants in this study must be on the waiting list for a liver transplant with a ReMELD-Na-Score of 21 or less (equivalent to MELD ≤25) and must not qualify for certain special exceptions. Participants will be randomly placed into one of two groups:

* Experimental group: In addition to regular organ offers, these participants may receive a liver that was initially not considered for transplantation but meets quality standards after at least four hours of machine perfusion.
* Control group: These participants will receive a liver through the usual transplant process.

The main measure of success is how quickly participants receive a transplant. Researchers will also look at other important factors, such as survival rates, quality of life, hospital stay, and complications after transplant.

This study may help improve liver transplantation by making better use of available donor livers, reducing waiting times, and improving patient outcomes.

Conditions

Interventions

DEVICE

Quality Assessment with Normothermic Machine Perfusion (NMP)

Quality assessment using NMP in the experimental arm is performed according to previously published viability criteria for initially declined liver grafts, which are mandatory for all participating study centers, with minor device-specific modifications. These criteria are based on the Birmingham criteria used in the VITTAL trial for viability assessment of DBD and DCD grafts with the OrganOx Metra device and are comparable to the Groningen criteria used with the LiverAssist and PerLife device, with the exception of biliary viability. These criteria are: Lactate clearance \< 2.5 mmol/L, And two or more of the following: Evidence of bile production, maintenance of a perfusate pH \>7.30 (without correction for at least one hour), glucose metabolism (falling perfusate glucose value with consistent downward trend), maintenance of stable arterial and portal venous flows (OrganOx Metra: 150 and 500 mL/min respectively), homogeneous perfusion with soft consistency of the parenchyma.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2029-05-31
Completion
2030-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06874296 on ClinicalTrials.gov