Normothermic machine perfusion to re-evaluate declined donor livers and shorten 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
NA · Charite University, Berlin, Germany · NCT06874296
This trial tests whether keeping declined donor livers functioning on a normothermic perfusion machine can make more livers usable and help adults on the transplant waiting list (ReMELD‑Na ≤21) get transplanted sooner.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 10 sites (Hamburg, Free and Hanseatic City of Hamburg and 9 other locations) |
| Trial ID | NCT06874296 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) listed as transplantable at a participating center with ReMELD‑Na ≤21 (MELD ≤25), able to consent and medically suitable for transplantation with extended-criteria donor organs, who are not listed for retransplantation, high-urgency, or combined-organ transplant.
Not a fit: Patients listed for retransplantation, high-urgency or combined-organ transplants, pregnant patients, or those with higher MELD scores or special exception status are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, more donor livers could be used and eligible patients could receive transplants sooner with potentially better outcomes.
How similar studies have performed: Non-randomized studies from the UK, Netherlands, Australia, and the USA have shown NMP can increase organ utilization, but randomized evidence testing reassessment of declined grafts has been lacking until this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 9 other locations
- 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)
- Department of General, Visceral and Transplantation Surgery, LMU University Hospital, LMU Munich — München, Germany (RECRUITING)
- Department of Surgery, University Hospital Regensburg — Regensburg, Germany (RECRUITING)
- Eberhard Karls University of Tübingen, Department of General Visceral and Transplant Surgery — Tübingen, Germany (RECRUITING)
- Department of General, Visceral, Transplantation, Vascular, and Pediatric Surgery, University Hospital Wurzburg — Würzburg, Germany (RECRUITING)
Study contacts
- Study coordinator: Nathanael Raschzok, MD
- Email: nathanael.raschzok@charite.de
- Phone: +49 30 450 552 001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Transplantation, Liver Diseases, Surgery, Extended Criteria Donors, Normothermic Machine Perfusion, Discarded Liver Grafts