Evidence map›Paper›PMID 42595371›Full record

ArticleBMJ open2026

Open, prospective, randomised, multicentre trial on quality assessment of declined liver grafts by normothermic ex situ machine perfusion for decreasing time to transplantation (ExTra trial): a study protocol.

Simon Moosburner, Joseph M G V Gassner, Igor M Sauer, Mateja Mandac, Dominik P Modest, Dario Zocholl, Regina Stegherr, Madhukar S Patel, Julia Wendon, Christoph Roderburg and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06874296 (Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06874296 narecruitingnot on this map

Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2025 to 2030Enrolled186ConditionsLiver Transplantation, Liver Diseases, SurgeryArmsQuality Assessment with Normothermic Machine Perfusion (NMP)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Simon MoosburnerDepartment of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-1879-4788
Joseph M G V GassnerDepartment of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Igor M SauerDepartment of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Mateja MandacDepartment of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Dominik P ModestDepartment of Hematology, Oncology and Cancer Immunology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Dario ZochollInstitute of Biometry and Clinical Epidemiology, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Regina StegherrInstitute of Biometry and Clinical Epidemiology, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Madhukar S PatelDepartment of Surgery, Division of Surgical Transplantation, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Julia WendonInstitute of Liver Studies, School of Immunology and Microbial Sciences, King's College Hospital, London, UK.
Christoph RoderburgDepartment of Gastroenterology, Hepatology and Infectious Diseases, University Hospital of Düsseldorf, Düsseldorf, Germany.
Markus SelznerDepartment of Surgery, Ajmera Transplant Centre, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.
Andreas PascherDepartment of General, Visceral and Transplant Surgery, University Hospital Münster, Münster, Germany.
Uli FehrenbachDepartment of Radiology, Charite - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Johann PratschkeDepartment of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Nathanael RaschzokDepartment of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany nathanael.raschzok@charite.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLiver transplantation remains the only curative option for end-stage liver disease, yet high waitlist mortality and organ scarcity continue to challenge the field. The randomised multicentre ExTra trial aims to decrease time-to-transplant by safely improving access to transplantation through viability assessment of otherwise discarded grafts with normothermic machine perfusion (NMP). METHODS AND ANALYSIS: The ExTra trial is a prospective, randomised, multicentre study conducted across German transplant centres. Participants listed for liver transplantation with a reMELD-Na-Score ≤21 (refitted MELD-Natrium Score) who are not eligible for Standard or Non-Standard Exceptions will be randomised for a 1-year intervention period into two groups: the experimental arm, in which they have-in addition to regular organ allocation-the extra option to receive a graft that was initially deemed non-transplantable based on clinical criteria, but meets specified quality criteria after at least 4 hours of NMP, and the control arm, which consists of conventional allocation procedures alone. The primary endpoint is time-to-transplant, defined as the period between randomisation and transplantation. Secondary outcomes include competing events (death, disease progression or recovery without transplantation), graft and patient survival, quality of life and cost-effectiveness. Additional analyses will assess early graft function, length of hospital stay, biliary complications and 1-year post-transplant outcomes. A centralised biobank will collect perfusate, tissue and blood samples for biomarker research. Safety will be monitored through quarterly reviews by a Data Safety Monitoring Board. ETHICS AND DISSEMINATION: The study protocol received approval from the Institutional Review Board of the Charité - Universitätsmedizin Berlin on 2 April 2025 (EA1/04/25). Participating study centres will need local Institutional Review Board approval prior to initiation. This study complies with Good Clinical Practice guidelines and all applicable national and local regulations. Results will be disseminated during international and national conference meetings and through publication in a peer-reviewed journal with open access. TRIAL REGISTRATION NUMBER: NCT06874296.

Indexed as

End Stage Liver DiseaseLiver TransplantationOrgan PreservationPerfusionGermanyGraft SurvivalHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicWaiting ListsRandomized Controlled TrialSURGERYTRANSPLANT MEDICINE

Identifiers

PMID42595371
PMCPMC13475461

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.