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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07570901
Acronym
HDMELD in LT
Enrollment
446
Registered
2026-05-06
Start date
2010-01-01
Completion date
2025-12-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease (Alcoholic or Not), Liver Transplantation

Keywords

liver transplantation, MELD, delta MELD, patient survival, liver allocation

Brief summary

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.

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.

Interventions

None listed

Sponsors

University of Jena
Lead SponsorOTHER
University Health Network, Toronto
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
overall mortality of LT recipientsminimal follow up of 12 months up to fifteen yearsoverall mortality of liver transplant recipients

Secondary

MeasureTime frameDescription
Perioperative lenght of intensive care unit (ICU) stayperioperative ICU stay, measured in days following liver transplantation maximal 24 weeksPerioperative length of intensive care unit treatment in days,

Countries

Canada, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026