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

RecruitingNAAges 18 Years - anyAllCharite University, Berlin, Germany
NCT06874296 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: * Experime

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Listed for retransplantation * High-Urgency Listing * Listed for combined organ transplantation * Pregnancy
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What it tests

  • Quality Assessment with Normothermic Machine Perfusion (NMP)
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Where

10 sites
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
University Hospital RWTH Aachen
Aachen, Germany
University Hospital Bonn
Bonn, Germany
University Hospital Muenster
Münster, Germany
Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
Berlin, Germany
Department of General, Visceral and Transplant Surgery, Hannover Medical School
Hanover, Germany
Department of General, Visceral and Transplantation Surgery, LMU University Hospital, LMU Munich
München, Germany
Department of Surgery, University Hospital Regensburg
Regensburg, Germany

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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