Living Donor Liver Transplantation in Children | NCT02124382

Studies
Living Donor Liver Transplantation in Children

NCT02124382

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Apr 28, 2014Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Pediatric Liver Transplanted Recipients
Healthy Donors

Interventions

Not provided

Countries

Not provided

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

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

Mar 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Apr 24, 2014

First Submission Date that Met QC Criteria

Apr 25, 2014

First Posted Date

Apr 28, 2014Estimated

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

Apr 25, 2014

Last Update Posted Date

Apr 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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

Detailed 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.

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

500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient and graft survival	Kaplan-Meier	10 years

Secondary Outcomes

Measure	Description	Time Frame
Portal vein complications		10 years

Other Outcomes

Measure	Description	Time Frame
Graft rejection free survival		10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children receiving a living donor liver transplant
Adult living donors

Exclusion Criteria:

No one

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

57 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raymond Reding, Md-PhD	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017093	Liver Failure
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided