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CompletedNCT07250919DR-MM in LTUpdated Feb 13, 2026

Donor and Recipient Mismatch in Liver Transplantation

An observational study in Patient Survival, Graft Survival and Liver Disease (Alcoholic or Not), sponsored by University of Jena. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by University of Jena · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,146
Ages
18 Years and older
Sex
All
01

Study summary

This observational study aims to investigate the impact of gender disparity between donors and recipients on long-term outcomes after liver transplantation (LT). The study aims to answer the following question:

Does gender mismatch lower the possibility of survival after liver transplantation? Participants demonstrate gender dicrepancies between donors and recipients as regular concept in LT. The retrospective cohort study investigates the impact over a long-term follow up of 10 years.

Read the detailed description

The study involves patients who undergo liver transplantation at the Ajmera Transplant Centre Toronto from 2014 until 2022. The observation period ended at the first January 2025 to provide a minimal follow up of 24 months.

Liver transplant recipients with gender mismatch (A) will be compared with liver transplant recipients without gender mismatch (B).

Liver transplantation is the only curative treatment for people with end stage liver disease. Gender mismatch between donor and recipient, particularly, the combination of a female donor to male recipient has been controversial in the past. Identifying risk factors that could affect the survival of the graft and recipient is of the utmost importance.

02

Conditions studied

  • Patient Survival
  • Graft Survival
  • Liver Disease (Alcoholic or Not)
  • Liver Transplant Surgery

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Keywords

  • liver transplantation
  • patient survival
  • gender mismatch
  • long-term outcome
  • organ allocation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who underwent liver transplantation at who at the Ajmera transplant centre, Toronto between 2014 and 2022

Inclusion criteria

  • Patients over the age of 18

Exclusion criteria

Exclusion Criteria:

  • Cases of retransplantation
  • Combined organ transplantation
  • Cases with >30% of missing values
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,146 participants (actual)
Patient registry
No

Groups and cohorts

  • GM +

    Liver transplant recipients with gender mismatch

  • GM -

    Liver transplant recipients without gender mismatch

05

What researchers measure

Primary outcomes

  1. Patient survival

    Overall survival of patients who underwent liver transplantation at the Ajmera transplant centre toronto between 2014 and 2022

    Time frame: Liver transplantation between 01.01.2014 and 01.01.2022, Patient Survival: observatory period between 01.01.2014 and 01.01.2024

06

Study locations

1 site
  • Ajmera Transplant Centre, Toronto General Hospital, University Health Network, Toronto
    Toronto, Ontario, Canada
07

References and documents

Publications

  • Ghinolfi D, Melandro F, Torri F, Martinelli C, Cappello V, Babboni S, Silvestrini B, De Simone P, Basta G, Del Turco S. Extended criteria grafts and emerging therapeutics strategy in liver transplantation. The unstable balance between damage and repair. Transplant Rev (Orlando). 2021 Dec;35(4):100639. doi: 10.1016/j.trre.2021.100639. Epub 2021 Jul 16. PubMed 34303259 ↗

Study documents

  • Study protocol · Feb 10, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — The investigators consider not to share IPD before publishing the study.

08

Registry details

Key details

Study ID
NCT07250919
Lead sponsor
University of Jena
Collaborators
University Health Network, Toronto
Responsible party
Nicola Sariye Pollmann (Principal Investigator, University of Jena) — Principal investigator
First posted
Nov 26, 2025
Start date
Jan 1, 2014
Primary completion
Jan 1, 2022
Completion
Jan 1, 2024
Last update
Feb 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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