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NCT Number: NCT07570901

Impact of Delta Model of End Stage Liver Disease (MELD) 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.

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Key information

Conditions

Liver Disease (Alcoholic or Not) Digestive System Diseases Liver Diseases Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. overall mortality of LT recipients

    Time frame: minimal follow up of 12 months up to fifteen years

    overall mortality of liver transplant recipients

Secondary outcomes

  1. Perioperative lenght of intensive care unit (ICU) stay

    Time frame: perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks

    Perioperative length of intensive care unit treatment in days,

Other outcomes

  1. postoperative assessment of liver function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: HDMELD in LT

Important dates

Study start
2010
Primary completion
2024
Study completion
2025
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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