Donor and Recipient Mismatch in Liver Transplantation | NCT07250919

Studies
Donor and Recipient Mismatch in Liver Transplantation

NCT07250919

Sponsor

University of Jena

Status

Completed

Last Update Posted

Feb 13, 2026Actual

Enrollment

1,146Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Nov 18, 2025

First Submission Date that Met QC Criteria

Nov 18, 2025

First Posted Date

Nov 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 13, 2026Actual

Name	Class
University Health Network, Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GM +		Liver transplant recipients with gender mismatch
GM -		Liver transplant recipients without gender mismatch

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient survival	Overall survival of patients who underwent liver transplantation at the Ajmera transplant centre toronto between 2014 and 2022	Liver transplantation between 01.01.2014 and 01.01.2022, Patient Survival: observatory period between 01.01.2014 and 01.01.2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over the age of 18

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Since gender discrepancies are studied, the participant are identified by their biological gender, including male and female.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajmera Transplant Centre, Toronto General Hospital, University Health Network, Toronto		Toronto	Ontario		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34303259	Background	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.