Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Contact Information
Primary
Nathanael Raschzok, MD
nathanael.raschzok@charite.de
+49 30 450 552 001
Backup
Simon Moosburner, MD
simon.moosburner@charite.de
+49 30 450 552 595
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 186
Treatments
No_intervention: Standard of care
Patient will be listed for liver transplantation through standard allocation only.
Experimental: ExTra Option
Patient will receive the option to receive a graft that was declined by all German Transplant Centers but meets predefined quality criteria during at least 4 hours of normothermic machine perfusion (ExTra-LT) or a liver via regular allocation - whichever occurs first.~Declined liver grafts will be allocated based on Eurotransplant's first-come-first-serve principle, with consideration for transport logistics and recipient eligibility. Only grafts meeting the following criteria will be considered: Macrovesicular steatosis \<60%, fibrosis grade \<F3, no histopathologic evidence of cirrhosis, graft weight between 1-2.5 kg, no previous machine perfusion preservation.
Related Therapeutic Areas
Sponsors
Collaborators: German Research Foundation
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov