- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02124382
Living Donor Liver Transplantation in Children
April 25, 2014 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Living Donor Liver Transplantation in Children: Surgical and Immunological Results in 250 Recipients at Université Catholique de Louvain.
Evaluate the outcome of pediatric living donor liver transplantation (LDLT) regarding portal vein reconstruction, ABO-compatibility and impact of maternal donation on graft acceptance.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 57 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
250 pediatric living donor liver transplant recipients 250 corresponding adult living donors
Description
Inclusion Criteria:
- Children receiving a living donor liver transplant
- Adult living donors
Exclusion Criteria:
- No one
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient and graft survival
Time Frame: 10 years
|
Kaplan-Meier
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Portal vein complications
Time Frame: 10 years
|
10 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Graft rejection free survival
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Raymond Reding, Md-PhD, Cliniques universitaires Saint-Luc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
April 24, 2014
First Submitted That Met QC Criteria
April 25, 2014
First Posted (Estimate)
April 28, 2014
Study Record Updates
Last Update Posted (Estimate)
April 28, 2014
Last Update Submitted That Met QC Criteria
April 25, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHIRPEDMG2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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