Liver Disease (Alcoholic or Not)HDMELD in LTNCT07570901
Impact of Delta Model of End Stage Liver Disease (MELD) in High MELD Liver Transplant Recipients
An observational study of Liver Disease (Alcoholic or Not) and Liver Transplantation, run by University of Jena at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease (Alcoholic or Not), Liver Transplantation
- How many people
- 446 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2010to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- first LT
- age above 18 years
- completeness of dataset
- liver only
Who cannot join
- second or higher LT
- age below 18 years
- incomplete dataset
- combined transplant
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Keywords
- liver transplantation, MELD, delta MELD, patient survival, liver allocation
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DMELD+ | liver transplant recipients with a positive delta MELD | |
| DMELD- | liver transplant recipients without delta MELD |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mortality of LT recipients
overall mortality of liver transplant recipients
Measured: minimal follow up of 12 months up to fifteen years
Secondary outcomes (1)
Perioperative lenght of intensive care unit (ICU) stay
Perioperative length of intensive care unit treatment in days,
Measured: perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jan 2010
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease (Alcoholic or Not)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Nicola Sariye Pollmann, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570901
- Sponsor's protocol ID
- 2026_07_02
- Acronym
- HDMELD in LT
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delta MELD as a Predictor of Decreased Survival in High MELD Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT07570901
- Acronym / sponsor ID
- HDMELD in LT / 2026_07_02
- Keywords
- liver transplantation, MELD, delta MELD, patient survival, liver allocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMELD+ | – | –liver transplant recipients with a positive delta MELD |
| DMELD- | – | –liver transplant recipients without delta MELD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- first LT
- age above 18 years
- completeness of dataset
- liver only
Key exclusion criteria (4 listed)
- second or higher LT
- age below 18 years
- incomplete dataset
- combined transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall mortality of LT recipients
Time frame: minimal follow up of 12 months up to fifteen years
overall mortality of liver transplant recipients
1 secondary outcome
Perioperative lenght of intensive care unit (ICU) stay
Time frame: perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease (Alcoholic or Not) and Liver Transplantation, run by University of Jena at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall mortality of LT recipients (time frame: minimal follow up of 12 months up to fifteen years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.