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

30. oktober 2026 opdateret af: University Medical Center Groningen

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

10000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Sabrina Stimmeder, MD
Telefonnummer: ‭+31503612896‬
E-mail: s.stimmeder@umcg.nl

Studiesteder

Belgien
- - Brussels, Belgien
    - Ikke rekrutterer endnu
    - Cliniques universitaires Saint-Luc
    - Kontakt:
      
      Eliano Bonaccorsi-Riani, MD, PhD
      
      Telefonnummer: +3227641111
      
      E-mail: Eliano.Bonaccorsi@saintluc.uclouvain.be
    - Ledende efterforsker:
      
      Eliano Bonaccorsi-Riani, MD, PhD
  - Ghent, Belgien
    - Ikke rekrutterer endnu
    - UZ Ghent
    - Kontakt:
      
      Hasan Eker, MD, PhD
      
      Telefonnummer: +3293322111
      
      E-mail: hasan.eker@uzgent.be
    - Ledende efterforsker:
      
      Hasan Eker, MD, PhD
  - Leuven, Belgien
    - Ikke rekrutterer endnu
    - University Hospitals Leuven
    - Kontakt:
      
      Diethard Monbaliu, MD, PhD
      
      Telefonnummer: +3216332211
      
      E-mail: diethard.monbaliu@uzleuven.be
    - Ledende efterforsker:
      
      Diethard Monbaliu, MD, PhD
Det Forenede Kongerige
- - Leeds, Det Forenede Kongerige
    - Ikke rekrutterer endnu
    - Leeds Teaching Hospitals NHS Trust
    - Kontakt:
      
      Dhakshina Vijayanand, MD, PhD
      
      Telefonnummer: +441132433144
      
      E-mail: dhakshina.vijayanand@nhs.net
    - Ledende efterforsker:
      
      Dhakshina Vijayanand, MD, PhD
  - London, Det Forenede Kongerige
    - Ikke rekrutterer endnu
    - Royal Free London NHS Foundation Trust
    - Kontakt:
      
      David Nasralla, MD, PhD
      
      Telefonnummer: +442077940500
      
      E-mail: david.nasralla@nhs.net
    - Ledende efterforsker:
      
      David Nasralla, MD, PhD
  - London, Det Forenede Kongerige
    - Ikke rekrutterer endnu
    - King's College Hospital NHS Foundation Trust
    - Kontakt:
      
      Miriam Cortes Cerisuelo, MD, PhD
      
      Telefonnummer: +442032999000
      
      E-mail: m.cortescerisuelo@nhs.net
    - Ledende efterforsker:
      
      Miriam Cortes Cerisuelo, MD, PhD
Frankrig
- - Clichy, Frankrig
    - Ikke rekrutterer endnu
    - Beaujon Hospital
    - Kontakt:
      
      Mickaël Lesurtel, MD, PhD
      
      Telefonnummer: +33140875000
      
      E-mail: mickael.lesurtel@aphp.fr
    - Ledende efterforsker:
      
      Mickaël Lesurtel, MD, PhD
  - Lyon, Frankrig
    - Ikke rekrutterer endnu
    - Hôpital de la Croix-Rousse
    - Kontakt:
      
      Xavier Muller, MD, PhD
      
      Telefonnummer: +33472118088
      
      E-mail: xavier.muller@chu-lyon.fr
    - Ledende efterforsker:
      
      Xavier Muller, MD, PhD
  - Strasbourg, Frankrig
    - Ikke rekrutterer endnu
    - Hautepierre Hospital
    - Kontakt:
      
      Pietro Francesco Addeo, MD, PhD
      
      Telefonnummer: +33388116768
      
      E-mail: pietrofrancesco.addeo@chru-strasbourg.fr
    - Ledende efterforsker:
      
      Pietro Francesco Addeo, MD, PhD
  - Villejuif, Frankrig
    - Ikke rekrutterer endnu
    - Hôpital Paul-Brousse Ap-Hp
    - Kontakt:
      
      Marc-Antoine Allard, MD, PhD
      
      Telefonnummer: +33145593000
      
      E-mail: marcantoine.allard@aphp.fr
    - Ledende efterforsker:
      
      Marc-Antoine Allard, MD, PhD
Holland
- - Groningen, Holland
    - Rekruttering
    - University Medical Center Groningen
    - Ledende efterforsker:
      
      Vincent E de Meijer, MD, PhD
    - Kontakt:
      
      Sabrina Stimmeder, MD
      
      Telefonnummer: +31503612896‬
      
      E-mail: s.stimmeder@umcg.nl
  - Leiden, Holland
    - Ikke rekrutterer endnu
    - Leiden University Medical Center
    - Kontakt:
      
      Ian Alwayn, MD, PhD
      
      Telefonnummer: +31715269111
      
      E-mail: i.p.j.alwayn@lumc.nl
    - Ledende efterforsker:
      
      Ian Alwayn, MD, PhD
Italien
- - Bari, Italien
    - Ikke rekrutterer endnu
    - A.O.U Consorziale Policlinico di Bari
    - Kontakt:
      
      Francesco Tandoi, MD, PhD
      
      Telefonnummer: +390805591111
      
      E-mail: francesco.tandoi@uniba.it
    - Ledende efterforsker:
      
      Francesco Tandoi, MD, PhD
  - Bergamo, Italien
    - Ikke rekrutterer endnu
    - Ospedale Papa Giovanni XXIII
    - Kontakt:
      
      Stefania Camagni, MD
      
      Telefonnummer: +39035267111
      
      E-mail: stefania.camagni@asst-pg23.it
    - Ledende efterforsker:
      
      Stefania Camagni, MD
    - Ledende efterforsker:
      
      Domenico Pinelli, MD, PhD
  - Bologna, Italien
    - Ikke rekrutterer endnu
    - Policlinico S.Orsola-Malpighi
    - Ledende efterforsker:
      
      Matteo Cescon, MD, PhD
    - Kontakt:
      
      Matteo Cescon, MD, PhD
      
      Telefonnummer: +390512141111
      
      E-mail: matteo.cescon@unibo.it
  - Milan, Italien
    - Ikke rekrutterer endnu
    - ASST Niguarda Great Metropolitan Hospital
    - Kontakt:
      
      Stefano Di Sandro, MD, PhD
      
      Telefonnummer: +390264441
      
      E-mail: stefano.disandro@unimore.it
    - Ledende efterforsker:
      
      Stefano Di Sandro, MD, PhD
  - Milan, Italien
    - Ikke rekrutterer endnu
    - Istituto Nazionale dei Tumori
    - Ledende efterforsker:
      
      Vincenzo Mazzaferro, MD, PhD
    - Kontakt:
      
      Marco Angelo MD, MSc, Bongini
      
      Telefonnummer: +390223901
      
      E-mail: marco.bongini@istitutotumori.mi.it
    - Underforsker:
      
      Marco Angelo Bongini, MD, MSc
  - Pisa, Italien
    - Ikke rekrutterer endnu
    - A.O.U. Pisana - Ospedale Cisanello
    - Kontakt:
      
      Davide Ghinolfi, MD, PhD
      
      Telefonnummer: +39050992111
      
      E-mail: d.ghinolfi@ao-pisa.toscana.it
    - Ledende efterforsker:
      
      Davide Ghinolfi, MD, PhD
  - Roma, Italien
    - Ikke rekrutterer endnu
    - Clinica ospedaliero-universitaria Policlinico Umberto I
    - Kontakt:
      
      Fabio Melandro, MD, PhD
      
      Telefonnummer: +390649971
      
      E-mail: fabio.melandro@uniroma1.it
    - Ledende efterforsker:
      
      Fabio Melandro, MD, PhD
    - Ledende efterforsker:
      
      Massimo Rossi, MD, PhD
  - Torino, Italien
    - Rekruttering
    - A.O.U. Città della Salute e della Scienza
    - Kontakt:
      
      Damiano Patrono, MD, PhD
      
      Telefonnummer: +39011693 3111
      
      E-mail: damiano.patrono@gmail.com
    - Ledende efterforsker:
      
      Damiano Patrono, MD, PhD
  - Verona, Italien
    - Ikke rekrutterer endnu
    - A.O.U. Integrata Verona
    - Kontakt:
      
      Amedeo Carraro, MD, PhD
      
      Telefonnummer: +390458121111
      
      E-mail: amedeo.carraro@aovr.veneto.it
    - Ledende efterforsker:
      
      Amedeo Carraro, MD, PhD
Schweiz
- - Bern, Schweiz
    - Ikke rekrutterer endnu
    - Bern University Hospital
    - Ledende efterforsker:
      
      Philipp Dutkowski, MD, PhD
    - Kontakt:
      
      Philipp Dutkowski, MD, PhD
      
      Telefonnummer: +41316322111
      
      E-mail: philipp.dutkowski@insel.ch
  - Geneva, Schweiz
    - Ikke rekrutterer endnu
    - Hôpitaux Universitaires de Genève
    - Kontakt:
      
      Philippe Compagnon, MD, PhD
      
      Telefonnummer: +41223723311
      
      E-mail: philippe.compagnon@hug.ch
    - Ledende efterforsker:
      
      Philippe Compagnon, MD, PhD
Spanien
- - Barakaldo, Spanien
    - Ikke rekrutterer endnu
    - Cruces University Hospital
    - Kontakt:
      
      Mikel Gastaca, MD, PhD
      
      Telefonnummer: +34946006000
      
      E-mail: mikel.gastacamateo@osakidetza.eus
    - Ledende efterforsker:
      
      Mikel Gastaca, MD, PhD
  - Barcelona, Spanien
    - Ikke rekrutterer endnu
    - Hospital Clínic de Barcelona
    - Kontakt:
      
      Yiliam Fundora Suárez, MD, PhD
      
      Telefonnummer: +34932275400
      
      E-mail: FUNDORA@clinic.cat
    - Ledende efterforsker:
      
      Yiliam Fundora Suárez, MD, PhD
  - Seville, Spanien
    - Ikke rekrutterer endnu
    - Hospital Universitario Virgen del Rocío
    - Kontakt:
      
      Sheila Pereira Arenas
      
      Telefonnummer: +34955012000
      
      E-mail: spereira-ibis@us.es
    - Ledende efterforsker:
      
      Miguel Angel Gómez Bravo, MD, PhD
Sverige
- - Stockholm, Sverige
    - Ikke rekrutterer endnu
    - Karolinska Institutet
    - Kontakt:
      
      Gabriel Oniscu, MD, PhD
      
      Telefonnummer: +46852480000
      
      E-mail: gabriel.oniscu@ki.se
    - Ledende efterforsker:
      
      Gabriel Oniscu, MD, PhD
Tyskland
- - Aachen, Tyskland
    - Ikke rekrutterer endnu
    - Aachen University Hospital
    - Kontakt:
      
      Florian Vondran, MD, PhD
      
      Telefonnummer: +49241800
      
      E-mail: fvondran@ukaachen.de
    - Ledende efterforsker:
      
      Florian Vondran, MD, PhD
  - Berlin, Tyskland
    - Ikke rekrutterer endnu
    - Charité - Universitätsmedizin Berlin
    - Kontakt:
      
      Nathanael Raschzok, MD, PhD
      
      Telefonnummer: +493045050
      
      E-mail: nathanael.raschzok@charite.de
    - Ledende efterforsker:
      
      Nathanael Raschzok, MD, PhD
  - Bonn, Tyskland
    - Ikke rekrutterer endnu
    - University Hospital Bonn
    - Kontakt:
      
      Christiane Pillny, MD
      
      Telefonnummer: +492282870
      
      E-mail: christiane.pillny@ukbonn.de
    - Ledende efterforsker:
      
      Christiane Pillny, MD
    - Ledende efterforsker:
      
      Steffen Manekeller, MD, PhD
  - Essen, Tyskland
    - Rekruttering
    - University Hospital Essen
    - Ledende efterforsker:
      
      Ulf Neumann, MD, PhD
    - Kontakt:
      
      Zoltan Czigany, MD, PhD
      
      Telefonnummer: +492017230
      
      E-mail: zoltan.czigany@uk-essen.de
    - Ledende efterforsker:
      
      Zoltan Czigany, MD, PhD
  - Hanover, Tyskland
    - Ikke rekrutterer endnu
    - Hannover Medical School
    - Kontakt:
      
      Moritz Schmelzle, MD, PhD
      
      Telefonnummer: +495115320
      
      E-mail: schmelzle.moritz@mh-hannover.de
    - Ledende efterforsker:
      
      Moritz Schmelzle, MD, PhD
  - Heidelberg, Tyskland
    - Ikke rekrutterer endnu
    - University Hospital Heidelberg
    - Kontakt:
      
      Peri Husen, MD, PhD
      
      Telefonnummer: +496221560
      
      E-mail: peri.husen@med.uni-heidelberg.de
    - Ledende efterforsker:
      
      Peri Husen, MD, PhD
    - Ledende efterforsker:
      
      Christoph Mickalski, MD, PhD
  - Magdeburg, Tyskland
    - Ikke rekrutterer endnu
    - University Hospital Magdeburg
    - Kontakt:
      
      Roland Croner, MD, PhD
      
      Telefonnummer: +493917601
      
      E-mail: roland.croner@med.ovgu.de
    - Ledende efterforsker:
      
      Roland Croner, MD, PhD
  - Münster, Tyskland
    - Ikke rekrutterer endnu
    - University Hospital Muenster
    - Kontakt:
      
      Philipp Houben, MD, PhD
      
      Telefonnummer: +492518355555
      
      E-mail: philipp.houben@ukmuenster.de
    - Ledende efterforsker:
      
      Philipp Houben, MD, PhD
    - Ledende efterforsker:
      
      Andreas Pascher, MD, PhD
  - Tübingen, Tyskland
    - Ikke rekrutterer endnu
    - Tübingen University Hospital
    - Kontakt:
      
      Silvio Nadalin, MD, PhD
      
      Telefonnummer: +497071290
      
      E-mail: silvio.nadalin@med.uni-tuebingen.de
    - Ledende efterforsker:
      
      Silvio Nadalin, MD, PhD
Østrig
- - Innsbruck, Østrig
    - Rekruttering
    - Medical University of Innsbruck
    - Kontakt:
      
      Stefan Schneeberger, MD, PhD
      
      Telefonnummer: +4351290030
      
      E-mail: stefan.schneeberger@i-med.ac.at
    - Ledende efterforsker:
      
      Stefan Schneeberger, MD, PhD
  - Vienna, Østrig
    - Ikke rekrutterer endnu
    - Medical University of Vienna
    - Kontakt:
      
      Deniz Uluk, MD
      
      Telefonnummer: +431401600
      
      E-mail: deniz.uluk@meduniwien.ac.at
    - Ledende efterforsker:
      
      Deniz Uluk, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

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:
1. end-ischemic single- or dual hypothermic oxygenated MP [e(D)HOPE],
2. end-ischemic (back-to-base) normothermic MP [eNMP],
3. continuous (device-to-donor) normothermic MP [cNMP],
4. e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP [e(D)HOPE-COR-NMP)],
5. e(D)HOPE followed by normothermic MP [e(D)HOPE-NMP], or
6. Normothermic regional perfusion followed by SCS or an ex situ MP protocol.
A minimum follow-up of 12 months after liver transplantation is required.

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: COHORT
Tidsperspektiver: RETROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Death-censored graft survival Tidsramme: Actuarial survival 1-5 year post-transplantation	Defined as the time from liver transplantation until re-transplantation or death due to graft failure (analyzed using time-to-event methods).	Actuarial survival 1-5 year post-transplantation
Overall patient survival Tidsramme: Actuarial survival 1-5 year post-transplantation	Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods).	Actuarial survival 1-5 year post-transplantation

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Incidence of acute rejection Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation		within 1 year post-transplantation, up to 5 years post-transplantation
Incidence of chronic rejection Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation		within 1 year post-transplantation, up to 5 years post-transplantation
Overall graft survival Tidsramme: Actuarial survival 1-5 year post-transplantation	Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods)	Actuarial survival 1-5 year post-transplantation
Incidence of major liver-related complications Tidsramme: within the transplant-related admission, and 1 year post-transplantation	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.	within the transplant-related admission, and 1 year post-transplantation
Incidence of graft loss due to complications Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation	Graft loss as a result of complications assessed separately for biliary complications, vascular complications, and rejection.	within 1 year post-transplantation, up to 5 years post-transplantation
Total number of clinically significant biliary complications Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation	Total number of any biliary complications requiring interventions (Clavien-Dindo grade IIIa or higher).	within 1 year post-transplantation, up to 5 years post-transplantation
Incidence of biliary complications Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation	Biliary complications include: Post-transplant cholangiopathy Anastomotic strictures Biliary leakage	within 1 year post-transplantation, up to 5 years post-transplantation
Incidence of vascular complications Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation	Vascular complications include: Hepatic artery thrombosis Portal vein thrombosis Venous outflow tract obstruction	within 1 year post-transplantation, up to 5 years post-transplantation
Incidence of re-transplantation Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation	Re-transplantation for any cause.	within 1 year post-transplantation, up to 5 years post-transplantation
Incidence of recurrence of primary disease Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation	Histologically or radiologically confirmed recurrence, including recurrence of malignancies	within 1 year post-transplantation, up to 5 years post-transplantation
Incidence of kidney injury Tidsramme: within 1 year post-transplantation, up to 5 years post-transplantation	Kidney injury includes: Acute kidney injury New-onset chronic kidney disease	within 1 year post-transplantation, up to 5 years post-transplantation
Incidence of primary non-function Tidsramme: up to 1 week post-transplantation	Liver graft failure within the first 7 days of transplantation with patent liver vessels leading to re-transplantation or patient death	up to 1 week post-transplantation
Patient-centered outcomes (measure of recovery and healthcare utilization) Tidsramme: within 1 year post-transplantation	Length of intensive care unit stay and length of initial hospital stay (starting at day of transplantation until day of discharge, measured in days)	within 1 year post-transplantation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Medical Center Groningen

Samarbejdspartnere

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

Efterforskere

Ledende efterforsker: Vincent E de Meijer, MD, PhD, University Medical Center Groningen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. april 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

UMCG_REFRAME-MP
METc 2026/180 (Registry Identifier: UMCG METc number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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