NCT06874296 Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time
| NCT ID | NCT06874296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 186 participants in total. It began in 2025-06-02 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06874296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06874296 currently recruiting?
Yes, NCT06874296 is actively recruiting participants. Contact the research team at nathanael.raschzok@charite.de for enrollment information.
Where is the NCT06874296 trial being conducted?
This trial is being conducted at Hamburg, Germany, Aachen, Germany, Bonn, Germany, Münster, Germany and 6 additional locations.
Who is sponsoring the NCT06874296 clinical trial?
NCT06874296 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 186 participants.