Actively Recruiting
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
Eligibility Criteria
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
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
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
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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