NCT02124382

Brief Summary

Evaluate the outcome of pediatric living donor liver transplantation (LDLT) regarding portal vein reconstruction, ABO-compatibility and impact of maternal donation on graft acceptance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

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

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

April 24, 2014

Last Update Submit

April 25, 2014

Conditions

Pediatric Liver Transplanted RecipientsHealthy Donors

Keywords

liver failureliver malignancymetabolic diseasesPediatric liver transplanted recipients and their healthy donors

Outcome Measures

Primary Outcomes (1)

  • Patient and graft survival

    Kaplan-Meier

    10 years

Secondary Outcomes (1)

  • Portal vein complications

    10 years

Other Outcomes (1)

  • Graft rejection free survival

    10 years

Eligibility Criteria

AgeUp to 57 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

250 pediatric living donor liver transplant recipients 250 corresponding adult living donors

You may qualify if:

  • Children receiving a living donor liver transplant
  • Adult living donors

You may not qualify if:

  • No one

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver FailureMetabolic Diseases

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesNutritional and Metabolic Diseases

Study Officials

  • Raymond Reding, Md-PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 28, 2014

Study Start

March 1, 2012

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

April 28, 2014

Record last verified: 2014-04