Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time
Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation
Charite University, Berlin, Germany
186 participants
Jun 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Able to consent
- ≥ 18 years old
- Listed in status "transplantable" by the transplant conference of the study centre for liver transplantation, according to the guidelines of the German Medical Association valid at the time of inclusion
- ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for \[non\]standard exceptions
- Medically suitable and informed for transplantation with an organ that fulfils extended donor criteria (Eurotransplant ECD criteria)
- Patient information and written consent to participate in the Extra trial
- No participation in another interventional study during participation
Exclusion Criteria4
- Listed for retransplantation
- High-Urgency Listing
- Listed for combined organ transplantation
- Pregnancy
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Interventions
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.
Locations(9)
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NCT06874296