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

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Liver Disease (Alcoholic or Not)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 446

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• Germany
  • Thueringia
    • Jena, Thueringia, Germany, 07747
      • Jena University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
DMELD+; liver transplant recipients with a positive delta MELD
DMELD-; liver transplant recipients without delta MELD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall mortality of LT recipients	overall mortality of liver transplant recipients	minimal follow up of 12 months up to fifteen years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative lenght of intensive care unit (ICU) stay	Perioperative length of intensive care unit treatment in days,	perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative assessment of liver function	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

Collaborators and Investigators

• Sponsor: University of Jena
• Collaborators: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: liver transplantation; MELD; patient survival; delta MELD; liver allocation
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 2026_07_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No