Normothermic machine perfusion to re-evaluate declined donor livers and shorten transplant waiting time

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled study enrolls adults listed for liver transplantation with a ReMELD‑Na score ≤21 who are not eligible for non-standard exceptions. Participants are randomized to standard organ offers or to a group that, in addition to standard offers, may be offered livers previously declined that are re-assessed using normothermic machine perfusion (NMP), which keeps the organ working outside the body for objective quality testing. The trial examines whether NMP-based reassessment increases organ utilization, shortens waiting time, and improves post-transplant survival and clinical outcomes compared with current practice. It is conducted at three major German transplant centers and is the first randomized study to test NMP reassessment of declined grafts in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University Medical Center Hamburg-Eppendorf
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
• University Hospital RWTH Aachen
  Aachen, North Rhine-Westphalia, Germany Recruiting
• University Hospital Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting
• University Hospital Muenster
  Münster, North Rhine-Westphalia, Germany Recruiting
• Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
  Berlin, State of Berlin, Germany Recruiting
• Department of General, Visceral and Transplant Surgery, Hannover Medical School
  Hanover, Germany Recruiting

Study contacts

• Study coordinator: Nathanael Raschzok, MD
• Email: nathanael.raschzok@charite.de
• Phone: +49 30 450 552 001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.