ClinicalTrials.gg
RecruitingNCT07585890REFRAME-MPUpdated Nov 3, 2026

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

An observational study in End-stage Liver Disease (ESLD), Acute Liver Failure and Liver Cirrhosis, sponsored by University Medical Center Groningen. Recruiting at 38 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by University Medical Center Groningen · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Nov 3, 2026First sites in France and Spain30 sites added+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • End-stage Liver Disease (ESLD)
  • Acute Liver Failure
  • Liver Cirrhosis
  • Liver Transplantation

Keywords

  • machine perfusion
  • liver transplantation
  • hypothermic machine perfusion
  • normothermic machine perfusion
  • normothermic regional perfusion
  • organ preservation
  • machine preservation
03

In context

End Stage Liver Disease

154 studies on the registry are indexed under End Stage Liver Disease; 30 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 55 observational studies indexed under End Stage Liver Disease.

Browse End Stage Liver Disease studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Interventions

  • DeviceEndischemic hypothermic oxygenated machine perfusion (any 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.

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

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

  • DeviceContinuous (device-to-donor) normothermic machine perfusion (any device)

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

  • DeviceEndischemic HOPE-COR-NMP (any 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.

  • DeviceEndischemic HOPE-NMP (any 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.

  • DeviceNormothermic regional perfusion (any device)

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

  • OtherStatic cold storage

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

06

What researchers measure

Primary outcomes

  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).

    Time frame: 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).

    Time frame: Actuarial survival 1-5 year post-transplantation

Secondary outcomes

  1. Overall graft survival

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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

    Time frame: 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

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

  7. Incidence of re-transplantation

    Re-transplantation for any cause.

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

  8. Incidence of acute rejection

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

  9. Incidence of chronic rejection

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: within 1 year post-transplantation

07

Study locations

4 of 38 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

7 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2026
First posted
May 14, 2026
StartActual
Apr 21, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2030
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
30 sites added, 3 sites removed — first sites in France and Spain
Show 30 added (10 Germany, 8 Italy, 4 France, 3 Belgium, 3 Spain, 1 Switzerland, 1 United Kingdom)
  • UZ Ghent · Ghent, Belgium
  • CHU de Liège · Liège, Belgium
  • Aachen University Hospital · Aachen, Germany
  • Frankfurt University Hospital · Frankfurt, Germany
  • University Hospital Heidelberg · Heidelberg, Germany
  • Hôpitaux Universitaires de Genève · Geneva, Switzerland
  • Leeds Teaching Hospitals NHS Trust · Leeds, United Kingdom
  • Cliniques universitaires Saint-Luc · Brussels, Belgium
  • University Hospital Bonn · Bonn, Germany
  • University Medical Center Schleswig-Holstein, Campus Kiel · Kiel, Germany
  • University Hospital Magdeburg · Magdeburg, Germany
  • A.O.U Consorziale Policlinico di Bari · Bari, Italy
  • Ospedale Papa Giovanni XXIII · Bergamo, Italy
  • A.O.U. Pisana - Ospedale Cisanello · Pisa, Italy
  • Beaujon Hospital · Clichy, France
  • Hautepierre Hospital · Strasbourg, France
  • University Hospital Muenster · Münster, Germany
  • Policlinico S.Orsola-Malpighi · Bologna, Italy
  • Istituto Nazionale dei Tumori · Milan, Italy
  • Hôpital Paul-Brousse Ap-Hp · Villejuif, France
  • Hannover Medical School · Hanover, Germany
  • A.O.U. Integrata Verona · Verona, Italy
  • Cruces University Hospital · Barakaldo, Spain
  • Charité - Universitätsmedizin Berlin · Berlin, Germany
  • Hospital Clínic de Barcelona · Barcelona, Spain
  • Hospital Universitario Virgen del Rocío · Seville, Spain
  • Hôpital de la Croix-Rousse · Lyon, France
  • Tübingen University Hospital · Tübingen, Germany
  • ASST Niguarda Great Metropolitan Hospital · Milan, Italy
  • Clinica ospedaliero-universitaria Policlinico Umberto I · Roma, Italy
Show 3 removed
  • CHU de Liège · Liège, Belgium
  • Frankfurt University Hospital · Frankfurt, Germany
  • University Medical Center Schleswig-Holstein, Campus Kiel · Kiel, Germany
across 7 updates, Sep 25, 2026 – Nov 3, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • University Hospital Essen · Essen, GermanyContact u•••@uk-essen.de · •••7230→z•••@uk-essen.de · •••7230Contact person changed (no phone or email listed)
Sep 25, 2026
Show all 7 updates
  1. Nov 3, 2026
    4 sites added, 3 sites removed
    Show 4 added (2 Italy, 1 France, 1 Germany)
    • Hôpital de la Croix-Rousse · Lyon, France
    • Tübingen University Hospital · Tübingen, Germany
    • ASST Niguarda Great Metropolitan Hospital · Milan, Italy
    • Clinica ospedaliero-universitaria Policlinico Umberto I · Roma, Italy
    Show 3 removed
    • CHU de Liège · Liège, Belgium
    • Frankfurt University Hospital · Frankfurt, Germany
    • University Medical Center Schleswig-Holstein, Campus Kiel · Kiel, Germany
  2. Oct 22, 2026
    3 sites added
    Show 3 added (2 Spain, 1 Germany)
    • Charité - Universitätsmedizin Berlin · Berlin, Germany
    • Hospital Clínic de Barcelona · Barcelona, Spain
    • Hospital Universitario Virgen del Rocío · Seville, Spain
    + 1 other change: verification date
  3. Oct 15, 2026
    4 sites added — first site in Spain
    Show 4 added (1 France, 1 Germany, 1 Italy, 1 Spain)
    • Hôpital Paul-Brousse Ap-Hp · Villejuif, France
    • Hannover Medical School · Hanover, Germany
    • A.O.U. Integrata Verona · Verona, Italy
    • Cruces University Hospital · Barakaldo, Spain
  4. Oct 8, 2026
    5 sites added — first site in France
    Show 5 added (2 France, 2 Italy, 1 Germany)
    • Beaujon Hospital · Clichy, France
    • Hautepierre Hospital · Strasbourg, France
    • University Hospital Muenster · Münster, Germany
    • Policlinico S.Orsola-Malpighi · Bologna, Italy
    • Istituto Nazionale dei Tumori · Milan, Italy
  5. Oct 5, 2026
    6 sites added
    Show 6 added (3 Germany, 3 Italy)
    • University Hospital Bonn · Bonn, Germany
    • University Medical Center Schleswig-Holstein, Campus Kiel · Kiel, Germany
    • University Hospital Magdeburg · Magdeburg, Germany
    • A.O.U Consorziale Policlinico di Bari · Bari, Italy
    • Ospedale Papa Giovanni XXIII · Bergamo, Italy
    • A.O.U. Pisana - Ospedale Cisanello · Pisa, Italy
  6. Sep 30, 2026
    1 site added
    Show site
    • Cliniques universitaires Saint-Luc · Brussels, Belgium
  7. Sep 25, 2026
    7 sites added
    Show 7 added (3 Germany, 2 Belgium, 1 Switzerland, 1 United Kingdom)
    • UZ Ghent · Ghent, Belgium
    • CHU de Liège · Liège, Belgium
    • Aachen University Hospital · Aachen, Germany
    • Frankfurt University Hospital · Frankfurt, Germany
    • University Hospital Heidelberg · Heidelberg, Germany
    • Hôpitaux Universitaires de Genève · Geneva, Switzerland
    • Leeds Teaching Hospitals NHS Trust · Leeds, United Kingdom
    Site contacts Changed at 1 site. See the sites
    Show the site
    • University Hospital Essen · Essen, GermanyContact u•••@uk-essen.de · •••7230→z•••@uk-essen.de · •••7230Contact person changed (no phone or email listed)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07585890
Collaborators
A.O.U. Città della Salute e della Scienza
Responsible party
Sponsor
First posted
May 14, 2026
Start date
Apr 21, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

Sabrina Stimmeder, MD
Contact
s.stimmeder@umcg.nl
‭+31503612896‬
Vincent E de Meijer, MD, PhD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion