Living Donor Liver Transplantation in Children

Healthy Donors Clinical Trial

Official title:

Living Donor Liver Transplantation in Children: Surgical and Immunological Results in 250 Recipients at Université Catholique de Louvain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124382
• Other study ID #: CHIRPEDMG2012
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: April 25, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial 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.

Description:

Data from 250 pediatric LDLT recipients (and their donors), transplanted at Cliniques universitaires Saint-Luc between July 1993 and June 2012, were collected retrospectively using electronic data files. Results were analysed according to ABO matching and portal vein complications. Uni- and multi-variate analysis was used to study the impact of immunosuppression, gender match and maternal donation on acute rejection rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 57 Years

Eligibility

Inclusion Criteria:

• Children receiving a living donor liver transplant

• Adult living donors

Exclusion Criteria:

• No one

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Healthy Donors
• Pediatric Liver Transplanted Recipients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Graft rejection free survival		10 years	No
Primary	Patient and graft survival	Kaplan-Meier	10 years	No
Secondary	Portal vein complications		10 years	No