An observational study in Liver Disease (Alcoholic or Not) and Liver Transplantation, sponsored by University of Jena. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Jena · Observational
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.
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.
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.
Exclusion Criteria:
liver transplant recipients with a positive delta MELD
liver transplant recipients without delta MELD
overall mortality of LT recipients
overall mortality of liver transplant recipients
Time frame: minimal follow up of 12 months up to fifteen years
Perioperative lenght of intensive care unit (ICU) stay
Perioperative length of intensive care unit treatment in days,
Time frame: perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks
postoperative assessment of liver function
postopertative liver function measured by laboratory values
Time frame: laboratory values at routine follow-up appointments within 1 year following LT; usually at one, three, six and twelve months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — 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.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Jena