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

NCT07570901 | Completed

• 1 other identifier: 2026_07_02
• Study Type: observational
• Target: 446
• Locations: 2 countries
• Sites: 2

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.

Conditions

Liver Disease (Alcoholic or Not); Liver Transplantation

Keywords

liver transplantation; MELD; delta MELD; patient survival; liver allocation

Outcome Measures

Primary Outcomes (1)

• overall mortality of LT recipients

  overall mortality of liver transplant recipients

  minimal follow up of 12 months up to fifteen years

Secondary Outcomes (1)

• Perioperative lenght of intensive care unit (ICU) stay

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

Other Outcomes (1)

• postoperative assessment of liver function

  laboratory values at routine follow-up appointments within 1 year following LT; usually at one, three, six and twelve months

Study Arms (2)

DMELD+

liver transplant recipients with a positive delta MELD

DMELD-

liver transplant recipients without delta MELD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jena: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Jena University Hospital

Jena, Thueringia, 07747, Germany

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 6, 2026
• Study Start: January 1, 2010
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

DE (1); CA (1)