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Impact of Delta Model of End Stage Liver Disease (MELD) in High MELD Liver Transplant Recipients (HDMELD in LT)

1 maj 2026 uppdaterad av: Nicola Sariye Pollmann, University of Jena

Delta MELD as a Predictor of Decreased Survival in High MELD Liver Transplant Recipients

Liver transplantation (LT) represents an important curative option for end stage liver disease such as decompensated cirrhosis, which remains a major challenge for today's health care system. The Model for End-Stage Liver Disease (MELD) is a worldwide-established scoring system for the evaluation of the severity of liver disease in allocation processes. However, the interpretation of MELD in clinical practice, particularly with regard to prioritizing potential liver transplant recipients, has revealed some hazards. These include the adaptation of MELD based on patient's characteristics, e.g. the presence of hepatocellular carcinoma, kidney failure and cardiovascular disease. In addition, the remaining paucity of organ donors contributes to a rising number of transplantations of high MELD recipients. This leads to the risk of impaired outcomes, especially considering the interaction of additional donor and recipient risk factors, such as extended cold preservation, kidney function and warm ischemia. For a certain patient cohort living donation might represent a feasible approach as reported previously for high MELD patients.

Overall, the interaction of donor and recipient characteristics on the outcomes after LT in high MELD patients remains a scarcely investigated field. Therefore, the identification of factors influencing patient's outcomes after orthotopic liver transplantation becomes increasingly important, especially in high MELD recipients.

Studieöversikt

Detaljerad beskrivning

The underlying study aims to investigate several questions. The sodium corrected MELD score is the cornerstone of liver allocation, prioritizing patients with the highest short-term mortality risk. However, outcomes after transplantation among recipients with very high MELD scores remain heterogeneous. While some critically ill patients recover and achieve favorable long-term survival, others experience early post-transplant mortality, raising concerns about futile transplantation in a subset of high-risk candidates.

Current allocation systems rely on a static MELD value at the time of transplantation, which may not fully capture the dynamic trajectory of liver disease, the relative contribution of individual MELD components, or the interaction between recipient severity and donor graft characteristics. Improved risk stratification within the high MELD population is therefore needed to better balance urgency and utility in liver allocation.

Primary Objective

To determine whether changes in MELD score (delta MELD) prior to transplantation are predictive of post-transplant survival in high MELD recipients.

Secondary Objectives

To identify clinical and biochemical characteristics associated with futile liver transplantation, defined as early post-transplant mortality among recipients with very high MELD scores.

To evaluate whether exceeding a MELD threshold of 30 is independently associated with poor post-transplant outcomes.

Studietyp

Observationell

Inskrivning (Faktisk)

446

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Ontario
      • Toronto, Ontario, Kanada, M5G 2C4
        • Toronto General Hospital
    • Thueringia
      • Jena, Thueringia, Tyskland, 07747
        • Jena University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

patients who underwent LT between 2010 and 2025 who were listed with a high MELD at the time of LT ( above 30). LT-R who had a high change of MELD ( above 10 points within 30 days) were assigned to the DMELD+ group, LT recipients without this accelaration were assigned to the DMELD- group.

Beskrivning

Inclusion Criteria:

  • first LT
  • age above 18 years
  • completeness of dataset
  • liver only

Exclusion Criteria:

  • second or higher LT
  • age below 18 years
  • incomplete dataset
  • combined transplant

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
DMELD+
liver transplant recipients with a positive delta MELD
DMELD-
liver transplant recipients without delta MELD

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
overall mortality of LT recipients
Tidsram: minimal follow up of 12 months up to fifteen years
overall mortality of liver transplant recipients
minimal follow up of 12 months up to fifteen years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Perioperative lenght of intensive care unit (ICU) stay
Tidsram: perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks
Perioperative length of intensive care unit treatment in days,
perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
postoperative assessment of liver function
Tidsram: laboratory values at routine follow-up appointments within 1 year following LT; usually at one, three, six and twelve months
postopertative liver function measured by laboratory values
laboratory values at routine follow-up appointments within 1 year following LT; usually at one, three, six and twelve months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2010

Primärt slutförande (Faktisk)

31 december 2024

Avslutad studie (Faktisk)

31 december 2025

Studieregistreringsdatum

Först inskickad

24 april 2026

Först inskickad som uppfyllde QC-kriterierna

1 maj 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026_07_02

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

Participant data is planned to be published within a manuscript, however data will be anonymized. Nevertheless, if asked for by reviewers or other researchers who have questions regarding the study, anonymized IPD will be provided.

Läkemedels- och apparatinformation, studiedokument

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