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End-stage Liver Disease (ESLD)REFRAME-MPNCT07585890

Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe

An observational study of End-stage Liver Disease (ESLD) and Acute Liver Failure, run by University Medical Center Groningen at 37 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Endischemic hypothermic oxygenated machine perfusion (any device), Endischemic (back-to-base) normothermic machine perfusion (any device) and Continuous (device-to-donor) normothermic machine perfusion (any device)
Type of treatment
Medical device
How many people
10,000 participants
Where
37 sitesin 10 countries
Study dates
21 Apr 2026to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer between 01.01.2021 and 31.12.2025 for patients >18 years at the time of liver transplantation.

Who may be able to join

  • All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients >18 years at the time of liver transplantation.
  • All donor types (DBD, DCD)
  • Preservation either with static cold storage alone or combined with machine perfusion (MP).
  • Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.
  • Eligible MP protocols are:
  • end-ischemic single- or dual hypothermic oxygenated MP [e(D)HOPE],
Show all 12Show fewer
  • end-ischemic (back-to-base) normothermic MP [eNMP],
  • continuous (device-to-donor) normothermic MP [cNMP],
  • e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP [e(D)HOPE-COR-NMP)],
  • e(D)HOPE followed by normothermic MP [e(D)HOPE-NMP], or
  • Normothermic regional perfusion followed by SCS or an ex situ MP protocol.
  • A minimum follow-up of 12 months after liver transplantation is required.

Who cannot join

  • Livers that were allocated to a MP protocol as part of a prospective randomized or interventional clinical trial comparing different preservation techniques or any other invention.
  • Living donor liver transplantation

Trial locations and contacts

37 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Sabrina Stimmeder, MD contact

‭+31503612896‬

s.stimmeder@umcg.nl

37 sites in 10 countries

Germany10 sites, 10 recruiting

  • Aachen University Hospital

    Aachen

    Florian Vondran, MD, PhD, +49241800, fvondran@ukaachen.de

    Florian Vondran, MD, PhD

    Not yet recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin

    Nathanael Raschzok, MD, PhD, +493045050, nathanael.raschzok@charite.de

    Nathanael Raschzok, MD, PhD

    Not yet recruiting

  • University Hospital Bonn

    Bonn

    Christiane Pillny, MD, +492282870, christiane.pillny@ukbonn.de

    Christiane Pillny, MD

    Not yet recruiting

  • University Hospital Essen

    Essen

    Zoltan Czigany, MD, PhD, +492017230, zoltan.czigany@uk-essen.de

    Ulf Neumann, MD, PhD

    Recruiting

  • Frankfurt University Hospital

    Frankfurt

    Tamás Benkö, MD, PhD, +496963010, tamas.benkoe@unimedizin-ffm.de

    Tamás Benkö, MD, PhD

    Not yet recruiting

  • Hannover Medical School

    Hanover

    Moritz Schmelzle, MD, PhD, +495115320, schmelzle.moritz@mh-hannover.de

    Moritz Schmelzle, MD, PhD

    Not yet recruiting

  • University Hospital Heidelberg

    Heidelberg

    Peri Husen, MD, PhD, +496221560, peri.husen@med.uni-heidelberg.de

    Peri Husen, MD, PhD

    Not yet recruiting

  • University Medical Center Schleswig-Holstein, Campus Kiel

    Kiel

    Felix Braun, MD, PhD, +494315000, felix.braun@uksh.de

    Felix Braun, MD, PhD

    Not yet recruiting

  • University Hospital Magdeburg

    Magdeburg

    Roland Croner, MD, PhD, +493917601, roland.croner@med.ovgu.de

    Roland Croner, MD, PhD

    Not yet recruiting

  • University Hospital Muenster

    Münster

    Philipp Houben, MD, PhD, +492518355555, philipp.houben@ukmuenster.de

    Philipp Houben, MD, PhD

    Not yet recruiting

Other trials in Germany

Italy7 sites, 7 recruiting

  • A.O.U Consorziale Policlinico di Bari

    Bari

    Francesco Tandoi, MD, PhD, +390805591111, francesco.tandoi@uniba.it

    Francesco Tandoi, MD, PhD

    Not yet recruiting

  • Ospedale Papa Giovanni XXIII

    Bergamo

    Stefania Camagni, MD, +39035267111, stefania.camagni@asst-pg23.it

    Stefania Camagni, MD

    Not yet recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna

    Matteo Cescon, MD, PhD, +390512141111, matteo.cescon@unibo.it

    Matteo Cescon, MD, PhD

    Not yet recruiting

  • Istituto Nazionale dei Tumori

    Milan

    Marco Angelo MD, MSc, Bongini, +390223901, marco.bongini@istitutotumori.mi.it

    Vincenzo Mazzaferro, MD, PhD

    Not yet recruiting

  • A.O.U. Pisana - Ospedale Cisanello

    Pisa

    Davide Ghinolfi, MD, PhD, +39050992111, d.ghinolfi@ao-pisa.toscana.it

    Davide Ghinolfi, MD, PhD

    Not yet recruiting

  • A.O.U. Città della Salute e della Scienza

    Torino

    Damiano Patrono, MD, PhD, +39011693 3111, damiano.patrono@gmail.com

    Damiano Patrono, MD, PhD

    Recruiting

  • A.O.U. Integrata Verona

    Verona

    Amedeo Carraro, MD, PhD, +390458121111, amedeo.carraro@aovr.veneto.it

    Amedeo Carraro, MD, PhD

    Not yet recruiting

Other trials in Italy

Belgium4 sites, 4 recruiting

  • Cliniques universitaires Saint-Luc

    Brussels

    Eliano Bonaccorsi-Riani, MD, PhD, +3227641111, Eliano.Bonaccorsi@saintluc.uclouvain.be

    Eliano Bonaccorsi-Riani, MD, PhD

    Not yet recruiting

  • UZ Ghent

    Ghent

    Hasan Eker, MD, PhD, +3293322111, hasan.eker@uzgent.be

    Hasan Eker, MD, PhD

    Not yet recruiting

  • University Hospitals Leuven

    Leuven

    Diethard Monbaliu, MD, PhD, +3216332211, diethard.monbaliu@uzleuven.be

    Diethard Monbaliu, MD, PhD

    Not yet recruiting

  • CHU de Liège

    Liège

    Nicholas Gilbo, MD, PhD, +3243230000, nicholas.gilbo@chuliege.be

    Nicholas Gilbo, MD, PhD

    Not yet recruiting

Other trials in Belgium

France3 sites, 3 recruiting

  • Beaujon Hospital

    Clichy

    Mickaël Lesurtel, MD, PhD, +33140875000, mickael.lesurtel@aphp.fr

    Mickaël Lesurtel, MD, PhD

    Not yet recruiting

  • Hautepierre Hospital

    Strasbourg

    Pietro Francesco Addeo, MD, PhD, +33388116768, pietrofrancesco.addeo@chru-strasbourg.fr

    Pietro Francesco Addeo, MD, PhD

    Not yet recruiting

  • Hôpital Paul-Brousse Ap-Hp

    Villejuif

    Marc-Antoine Allard, MD, PhD, +33145593000, marcantoine.allard@aphp.fr

    Marc-Antoine Allard, MD, PhD

    Not yet recruiting

Other trials in France

Spain3 sites, 3 recruiting

  • Cruces University Hospital

    Barakaldo

    Mikel Gastaca, MD, PhD, +34946006000, mikel.gastacamateo@osakidetza.eus

    Mikel Gastaca, MD, PhD

    Not yet recruiting

  • Hospital Clínic de Barcelona

    Barcelona

    Yiliam Fundora Suárez, MD, PhD, +34932275400, FUNDORA@clinic.cat

    Yiliam Fundora Suárez, MD, PhD

    Not yet recruiting

  • Hospital Universitario Virgen del Rocío

    Seville

    Sheila Pereira Arenas, +34955012000, spereira-ibis@us.es

    Miguel Angel Gómez Bravo, MD, PhD

    Not yet recruiting

Other trials in Spain

United Kingdom3 sites, 3 recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds

    Dhakshina Vijayanand, MD, PhD, +441132433144, dhakshina.vijayanand@nhs.net

    Dhakshina Vijayanand, MD, PhD

    Not yet recruiting

  • King's College Hospital NHS Foundation Trust

    London

    Miriam Cortes Cerisuelo, MD, PhD, +442032999000, m.cortescerisuelo@nhs.net

    Miriam Cortes Cerisuelo, MD, PhD

    Not yet recruiting

  • Royal Free London NHS Foundation Trust

    London

    David Nasralla, MD, PhD, +442077940500, david.nasralla@nhs.net

    David Nasralla, MD, PhD

    Not yet recruiting

Other trials in United Kingdom

Austria2 sites, 2 recruiting

  • Medical University of Innsbruck

    Innsbruck

    Stefan Schneeberger, MD, PhD, +4351290030, stefan.schneeberger@i-med.ac.at

    Stefan Schneeberger, MD, PhD

    Recruiting

  • Medical University of Vienna

    Vienna

    Deniz Uluk, MD, +431401600, deniz.uluk@meduniwien.ac.at

    Deniz Uluk, MD

    Not yet recruiting

Other trials in Austria

Netherlands2 sites, 2 recruiting

  • University Medical Center Groningen

    Groningen

    Sabrina Stimmeder, MD, +31503612896‬, s.stimmeder@umcg.nl

    Vincent E de Meijer, MD, PhD

    Recruiting

  • Leiden University Medical Center

    Leiden

    Ian Alwayn, MD, PhD, +31715269111, i.p.j.alwayn@lumc.nl

    Ian Alwayn, MD, PhD

    Not yet recruiting

Other trials in Netherlands

Switzerland2 sites, 2 recruiting

  • Bern University Hospital

    Bern

    Philipp Dutkowski, MD, PhD, +41316322111, philipp.dutkowski@insel.ch

    Philipp Dutkowski, MD, PhD

    Not yet recruiting

  • Hôpitaux Universitaires de Genève

    Geneva

    Philippe Compagnon, MD, PhD, +41223723311, philippe.compagnon@hug.ch

    Philippe Compagnon, MD, PhD

    Not yet recruiting

Other trials in Switzerland

Sweden1 site, 1 recruiting

  • Karolinska Institutet

    Stockholm

    Gabriel Oniscu, MD, PhD, +46852480000, gabriel.oniscu@ki.se

    Gabriel Oniscu, MD, PhD

    Not yet recruiting

Other trials in Sweden

About this study

Official title: Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)

Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Consequently, many studies continue to reference historical benchmark cohorts from the pre-perfusion era, or use risk scores developed before routine utilization of MP. These cohorts, while once valuable, fail to account for the paradigm shift that MP has introduced. Likewise, commonly used donor- and recipient-based risk scores were developed prior to the adoption of MP. While these scores aim to assess survival or morbidity after transplantation, none of them guide decisions about MP use or the most suitable perfusion protocol. As MP technologies continue to evolve there is a critical need for an updated reference framework that accurately reflects current clinical practice and captures the best achievable outcomes across all MP modalities.

Read the detailed description

The aim of this study is to establish a reference framework for liver transplantation outcomes in the era of routine clinical machine perfusion. In addition, based on the collected real-world observational data, a target trial emulation approach will be applied.

Being tested
Endischemic hypothermic oxygenated machine perfusion (any device), Endischemic (back-to-base) normothermic machine perfusion (any device), Continuous (device-to-donor) normothermic machine perfusion (any device), Endischemic HOPE-COR-NMP (any device), Endischemic HOPE-NMP (any device)
Keywords
machine perfusion, liver transplantation, hypothermic machine perfusion, normothermic machine perfusion, normothermic regional perfusion, organ preservation, machine preservation
Medical subject headings
End Stage Liver Disease, Liver Failure, Acute, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endischemic hypothermic oxygenated machine perfusion (any device)Device

    Endischemic single- or dual hypothermic oxygenated machine perfusion. Normothermic regional perfusion prior to single- or dual hypothermic oxygenated machine perfusion is eligible for inclusion.

  • Endischemic (back-to-base) normothermic machine perfusion (any device)Device

    Endischemic (back-to-base) normothermic machine perfusion. Normothermic regional perfusion prior to endischemic (back-to-base) normothermic machine perfusion is eligible for inclusion.

  • Continuous (device-to-donor) normothermic machine perfusion (any device)Device

    Continuous (device-to-donor) normothermic machine perfusion. Normothermic regional perfusion prior to continuous (device-to-donor) normothermic machine perfusion is eligible for inclusion.

  • Endischemic HOPE-COR-NMP (any device)Device

    Endischemic single or dual hypothermic oxygenated machine perfusion followed by controlled oxygenated rewarming and normothermic machine perfusion.

    Normothermic regional perfusion prior to HOPE-COR-NMP is eligible for inclusion.

  • Endischemic HOPE-NMP (any device)Device

    Endischemic single or dual hypothermic oxygenated machine perfusion followed by normothermic machine perfusion.

    Normothermic regional perfusion prior to HOPE-NMP is eligible for inclusion.

  • Normothermic regional perfusion (any device)Device

    Normothermic regional perfusion followed by static cold storage or any ex situ machine perfusion protocol.

  • Static cold storageOther

    Preservation with static cold storage only, not preceeded by NRP, nor followed by ex situ machine perfusion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death-censored graft survival

    Defined as the time from liver transplantation until re-transplantation or death due to graft failure (analyzed using time-to-event methods).

    Measured: Actuarial survival 1-5 year post-transplantation

  2. Overall patient survival

    Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods).

    Measured: Actuarial survival 1-5 year post-transplantation

Secondary outcomes (13)

  1. Overall graft survival

    Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods)

    Measured: Actuarial survival 1-5 year post-transplantation

  2. Incidence of major liver-related complications

    Incidence of at least one biliary or vascular complication graded as Clavien-Dindo IIIb or higher, following the grading recommendations published: de Goeij FHC, Wehrle CJ, Abbassi F, et al. Mastering the narrative: Precision reporting of risk and outcomes in liver transplantation. J Hepatol. 2025;82(4):729-743. doi:10.1016/j.jhep.2024.11.013. Additionally, scoring accoring the Comprehensive Complication Index.

    Measured: within the transplant-related admission, and 1 year post-transplantation

  3. Incidence of graft loss due to complications

    Graft loss as a result of complications assessed separately for biliary complications, vascular complications, and rejection.

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  4. Total number of clinically significant biliary complications

    Total number of any biliary complications requiring interventions (Clavien-Dindo grade IIIa or higher).

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  5. Incidence of biliary complications

    Biliary complications include:

    • Post-transplant cholangiopathy
    • Anastomotic strictures
    • Biliary leakage

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  6. Incidence of vascular complications

    Vascular complications include:

    • Hepatic artery thrombosis
    • Portal vein thrombosis
    • Venous outflow tract obstruction

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  7. Incidence of re-transplantation

    Re-transplantation for any cause.

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  8. Incidence of acute rejection

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  9. Incidence of chronic rejection

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  10. Incidence of recurrence of primary disease

    Histologically or radiologically confirmed recurrence, including recurrence of malignancies

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  11. Incidence of kidney injury

    Kidney injury includes:

    • Acute kidney injury
    • New-onset chronic kidney disease

    Measured: within 1 year post-transplantation, up to 5 years post-transplantation

  12. Incidence of primary non-function

    Liver graft failure within the first 7 days of transplantation with patent liver vessels leading to re-transplantation or patient death

    Measured: up to 1 week post-transplantation

  13. Patient-centered outcomes (measure of recovery and healthcare utilization)

    Length of intensive care unit stay and length of initial hospital stay (starting at day of transplantation until day of discharge, measured in days)

    Measured: within 1 year post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start21 Apr 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07585890
Sponsor's protocol ID
UMCG_REFRAME-MP
Other IDs
METc 2026/180
Acronym
REFRAME-MP
Status last verified
Oct 2026
First submitted
21 Apr 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of End-stage Liver Disease (ESLD) and Acute Liver Failure, run by University Medical Center Groningen at 37 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, Italy, Belgium, France, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sabrina Stimmeder, MD (‭+31503612896‬, s.stimmeder@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death-censored graft survival (time frame: Actuarial survival 1-5 year post-transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07585890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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