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

30. oktober 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

10000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: COHORT
Tidsperspektiver: RETROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Medical Center Groningen

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. april 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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