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

NCT06874296 | Recruiting DMC

• 2 other identifiers: 20024292543051616
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 10

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.

Conditions

Liver Transplantation; Liver Diseases; Surgery

Keywords

Liver Transplantation; Extended Criteria Donors; Normothermic Machine Perfusion; Discarded Liver Grafts

Outcome Measures

Primary Outcomes (1)

• Time-to-Transplant

  From date of randomization to liver transplantation (up to 12 months after date of randomization)

Secondary Outcomes (8)

• Death

  From date of randomization to death (up to 12 months after date of randomization)

• Disease Progression

  From date of randomization to event (up to 12 months after date of randomization)

• Proportion of Patients Recovered on the Waitlist

  From date of randomization to event (up to 12 months after date of randomization)

• Number of patients listed for transplantation after 12 months

  12 months after randomization

• Overall patient survival

  From date of randomization to death (up to 24 months after date of randomization)

Other Outcomes (12)

• 3-month Graft Survival

  Within 3 months after date of liver transplantation

• 3-month Patient Survival

  Within 3 months after date of liver transplantation

• Patient Survival

  12 months after liver transplantation

Study Arms (2)

Standard of care

NO INTERVENTION

Patient will be listed for liver transplantation through standard allocation only.

ExTra Option

EXPERIMENTAL

Patients 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.

Device: Quality Assessment with Normothermic Machine Perfusion (NMP)

Interventions

Quality Assessment with Normothermic Machine Perfusion (NMP) DEVICE

Quality assessment using NMP in the experimental arm is performed according to previously published viability criteria for initially declined liver grafts, which are mandatory for all participating study centers, with minor device-specific modifications. These criteria are based on the Birmingham criteria used in the VITTAL trial for viability assessment of DBD and DCD grafts with the OrganOx Metra device and are comparable to the Groningen criteria used with the LiverAssist and PerLife device, with the exception of biliary viability. These criteria are: Lactate clearance \< 2.5 mmol/L, And two or more of the following: Evidence of bile production, maintenance of a perfusate pH \>7.30 (without correction for at least one hour), glucose metabolism (falling perfusate glucose value with consistent downward trend), maintenance of stable arterial and portal venous flows (OrganOx Metra: 150 and 500 mL/min respectively), homogeneous perfusion with soft consistency of the parenchyma.

ExTra Option

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to consent
• ≥ 18 years old
• 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

You may not qualify if:

• Listed for retransplantation
• High-Urgency Listing
• Listed for combined organ transplantation
• Pregnancy

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Research Foundation: collaborator

Study Sites (10)

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

RECRUITING

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

University Hospital Muenster

Münster, North Rhine-Westphalia, 49149, Germany

RECRUITING

Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, 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

Related Links

• Official Trial Homepage
• Funding Information

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Nathanael Raschzok, MD

CONTACT

+49 30 450 552 001; nathanael.raschzok@charite.de

Simon Moosburner, MD

CONTACT

+49 30 450 552 595; simon.moosburner@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The treatment in the intervention arm will be available for patient for 12 months after randomization. Patients who have not yet received a graft after 12 months and are therefore still on the waiting list are administratively censored.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 13, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)