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NCT Number: NCT06874296

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

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.

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Key information

Conditions

Liver Transplantation Digestive System Diseases Liver Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf, Hamburg, Free and Hanseatic City of Hamburg, Germany

Loading trial locations.

About this study

Liver transplantation is the treatment of choice for patients with advanced liver cirrhosis, hepatocellular carcinoma within the Milan criteria, and severe metabolic or autoimmune liver diseases. However, organ shortage remains a significant issue, particularly in Germany, where only 58% of patients on the waiting list received a transplant in 2022. Patients with MELD ≤25, who are ineligible for [Non]-Standard Exception criteria, face particularly long waiting times and lower transplant rates.

Despite the shortage, approximately 24% of all liver grafts in Germany are declined due to donor age, macrosteatosis, or prolonged cold ischemia. Emerging technologies, such as NMP, allow for objective graft quality assessment before transplantation. Several non-randomized studies in the UK, Netherlands, Australia, and the USA have demonstrated the potential of NMP to increase organ utilization. The ExTra trial is the first randomized controlled study to investigate whether declined liver grafts, following NMP-based quality assessment, can safely and effectively reduce the waiting time for patients with ReMELD-Na-Score ≤ 21(equivalent to MELD ≤25).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time-to-Transplant

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

Secondary outcomes

  1. Death

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

    Patient death during the 12-month intervention period, regardless of liver transplantation or not.

  2. Disease Progression

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

    Change of ReMELD-Na-Score above 21 while listed as "transplantable" on the waitlist. Occurence of new contraindication for liver transplantation

  3. Proportion of Patients Recovered on the Waitlist

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

    Proportion of patients with change in overall health that no liver transplantation is further required in relation to all patients on the waitlist in the trial.

  4. Number of patients listed for transplantation after 12 months

    Time frame: 12 months after randomization

    Number of patients listed for transplantation after 12 months.

  5. Overall patient survival

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

    Overall patient survival in the study.

  6. Patient-reported Quality of Life

    Time frame: up to 24 months

    Patient-reported Quality of Life measured in the EuroQOL EQ5DL. Two aspects will be reported: The EuroQOL visual analog scale (EQ VAS) on a scale from 0-100 points and the proportion of responses by level of severity for the five EQ-5D-5L dimensions (each reported on a five level scale).

  7. Graft utilization rate

    Time frame: up to 12 months

    Proportion of used livers of all organs offered to patients on the waiting list

  8. Inpatient Costs for Liver Transplantation

    Time frame: First 90 days after liver transplantation

    Analysis of liver transplantation-associated costs. This will be total costs, earnings and profit measured in Euros (EUR) for the primary inpatient stay of liver transplantation.

Other outcomes

  1. 3-month Graft Survival

    Time frame: Within 3 months after date of liver transplantation

    Graft survival is defined as the need for retransplantation within the first 3 months after liver transplantation. This is one of the "Safety" endpoints and will be evaluated by the Data Safety Monitoring Board.

  2. 3-month Patient Survival

    Time frame: Within 3 months after date of liver transplantation

    Patient survival is defined as death within the first 3 months after liver transplantation. This is one of the "Safety" endpoints and will be evaluated by the Data Safety Monitoring Board.

  3. Patient Survival

    Time frame: 12 months after liver transplantation

    Patient Survival after liver transplantation

  4. Early graft function

    Time frame: Until 10 days after liver transplantation

    Early graft function measured by the Early Allograft Failure Simplified Estimation (EASE) Score on a scale from -6 (extremely low risk) to +6 (unsustainable risk).

  5. Intensive Care Unit Stay

    Time frame: First 30 days after liver transplantation

    Length of stay on the intensive care unit in days.

  6. Length of Hospital Stay

    Time frame: First 90 days after liver transplantation

    Total duration of days spent in the hospital after liver transplantation.

  7. Comprehensive Complication Index

    Time frame: Until 90 days after liver transplantation

    Post-transplant Comprehensive Complication Index, measured on a scale of 0-100, to quantify procedure related morbidity.

  8. Biliary Complications

    Time frame: Until 12 months after liver transplantation

    Ischemic-Type Biliary Lesions (clinically and as part of the planned MRCP 12 months after liver transplantation)

  9. Graft Survival

    Time frame: 12 months after liver transplantation

    Graft survival after liver transplantation.

  10. Acceptance Rate

    Time frame: Until 12 months after randomization

    1 / number of unrealized organ offers [accepted for the patient either primarily or within the extended/rescue allocation but not transplanted]

  11. Graft-Rescue Rate

    Time frame: Until 12 months after randomization

    Livers that meet quality criteria during NMP / all organs assessed through NMP in the study

  12. Risk of Graft Loss

    Time frame: On day of liver transplantation (within the 12 month intervention period after date of randomization)

    Risk of early graft loss as measured by the Balance of Risk (BAR) Score on a scale from 0-27.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathanael Raschzok, MD

CONTACT

[email protected]

+49 30 450 552 001

Simon Moosburner, MD

CONTACT

[email protected]

+49 30 450 552 595

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Acronym: ExTra

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Mar 13, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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