NCT06636409

Brief Summary

Liver transplantation is the primary intervention for decompensated chronic liver diseases and some cases of hepatocellular carcinoma. This study aims to examine long-term mortality after liver transplantation and identify related risk factors in the modern immunosuppression era, using a French multicenter cohort. This study does not interfere with patients' medical care. The study method involves collecting and analyzing only the essential data from patient records.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,343

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2023Aug 2028

Study Start

First participant enrolled

August 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2028

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

5 years

First QC Date

October 2, 2024

Last Update Submit

October 9, 2024

Conditions

Liver Transplant

Keywords

MortalityRisk factorsDecompensated chronic liver diseasesSurvivalImmunosuppression

Outcome Measures

Primary Outcomes (2)

  • Long-term mortality rates

    Evaluation of overall mortality rates among liver transplant recipients, measured from the time of transplantation until the end of the follow-up period.

    1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

  • Risk factors for mortality

    Identification of pre- and post-transplant risk factors associated with long-term mortality in liver transplant recipients. Risk factors include demographics (age, sex), comorbidities (diabetes, hypertension, cardiovascular diseases), and transplant-specific factors (MELD score, graft function).

    1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

Secondary Outcomes (6)

  • Demographic analysis of transplant recipients

    Baseline demographic analysis at 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

  • Factors influencing mortality rates

    1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

  • Progression of mortality risk factors

    1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

  • Mortality rates

    1 year and 5 years post-transplant

  • Liver transplant-specific risk factors

    1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up

  • +1 more secondary outcomes

Study Arms (1)

Liver transplant patients

Liver transplant patients from all French centers between 2008 and 2013 and followed up during the period 2008-2023.

Other: Collection of medical data

Interventions

Collection of medical dataOTHER

A randomised selection of files to be analyzed will be conducted in each center to constitute a representative sample of liver transplanted patients. This represents 20% of the number of transplanted patients over the period 2008-2013 in the center, allowing a more in-depth analysis of the patients' medical records.

Liver transplant patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had liver transplant between 2008 and 2013

You may qualify if:

  • Patients with liver transplant between 2008 and 2013 and follow up during 2008-2023

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Eloi, CHU de Montpellier

Montpellier, 34090, France

Location

Related Publications (2)

  • Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.

    PMID: 20486907RESULT

  • Dopazo C, Bilbao I, Castells LL, Sapisochin G, Moreiras C, Campos-Varela I, Echeverri J, Caralt M, Lazaro JL, Charco R. Analysis of adult 20-year survivors after liver transplantation. Hepatol Int. 2015 Jul;9(3):461-70. doi: 10.1007/s12072-014-9577-x. Epub 2014 Sep 18.

    PMID: 25788182RESULT

Study Officials

  • Magdalena MESZAROS, MD

    Saint Eloi-Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 10, 2024

Study Start

August 1, 2023

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

FR(1)