Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time
NCT ID: NCT06874296
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
186 participants
INTERVENTIONAL
2025-06-02
2030-12-31
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of care
Patient will be listed for liver transplantation through standard allocation only.
No interventions assigned to this group
ExTra Option
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.
Quality Assessment with Normothermic Machine Perfusion (NMP)
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.
Interventions
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Quality Assessment with Normothermic Machine Perfusion (NMP)
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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* High-Urgency Listing
* Listed for combined organ transplantation
* Pregnancy
18 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Nathanael Raschzok
Principal Investigator
Locations
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University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
University Hospital Muenster
Münster, North Rhine-Westphalia, Germany
Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Official Trial Homepage
Funding Information
Other Identifiers
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543051616
Identifier Type: OTHER
Identifier Source: secondary_id
20024292
Identifier Type: -
Identifier Source: org_study_id
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