Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06874296

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

Led by Charite University, Berlin, Germany · Updated on 2026-04-15

186

Participants Needed

10

Research Sites

291 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

G

German Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to consent
  • 18 years old or older
  • Listed as "transplantable" for liver transplantation by the transplant conference at the study center
  • ReMELD-Na-Score 21 or less (equivalent to MELD 25 or less), not eligible for non-standard exceptions
  • Medically suitable for transplantation with an organ meeting extended donor criteria
  • Provided patient information and written consent to participate in the trial
  • Not participating in another interventional study during this trial
Not Eligible

You will not qualify if you...

  • Listed for retransplantation
  • On high-urgency waiting list
  • Listed for combined organ transplantation
  • Pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251

Actively Recruiting

2

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, Germany, 52074

Actively Recruiting

3

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Actively Recruiting

4

University Hospital Muenster

Münster, North Rhine-Westphalia, Germany, 49149

Actively Recruiting

5

Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 13353

Actively Recruiting

6

Department of General, Visceral and Transplant Surgery, Hannover Medical School

Hanover, Germany

Actively Recruiting

7

Department of General, Visceral and Transplantation Surgery, LMU University Hospital, LMU Munich

München, Germany

Actively Recruiting

8

Department of Surgery, University Hospital Regensburg

Regensburg, Germany

Actively Recruiting

9

Eberhard Karls University of Tübingen, Department of General Visceral and Transplant Surgery

Tübingen, Germany

Actively Recruiting

10

Department of General, Visceral, Transplantation, Vascular, and Pediatric Surgery, University Hospital Wurzburg

Würzburg, Germany

Actively Recruiting

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Research Team

N

Nathanael Raschzok, MD

CONTACT

S

Simon Moosburner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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