NCT04814290

Brief Summary

Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
476

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

May 1, 2004

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

10 years

First QC Date

March 22, 2021

Last Update Submit

March 22, 2021

Conditions

Liver Transplantation

Keywords

Living-donor liver transplantationQuality of lifeFollow up

Outcome Measures

Primary Outcomes (1)

  • health-related quality of life (HRQoL)

    health-related quality of life (HRQoL) (36-item short-form health survey, version 1 \[SF-36\]).

    4 to 16 years of follow up

Study Arms (2)

living liver donors

cases already underwent hepatectomy for living-donor liver transplantation.

Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).

matched controls

healthy persons who attended the preoperative clinic while preparing for donation but were rejected because of an ABO blood group mismatch.

Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).

Interventions

health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).OTHER

health-related quality of life (HRQoL) (36-item short-form health survey, version 1 \[SF-36\]).

living liver donorsmatched controls

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

237 living liver donors and 239 matched controls.

You may qualify if:

  • age 18-50 years
  • no comorbidities.
  • BMI less than 30 kg/m2.
  • compatible ABO group.

You may not qualify if:

  • Older than 50 years.
  • Associated comorbidities.
  • Obesity.
  • Noncompatible ABO group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

May 1, 2004

Primary Completion

May 1, 2014

Study Completion

January 1, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03