Pediatric Liver Transplanted RecipientsNCT02124382
Living Donor Liver Transplantation in Children
An observational study of Pediatric Liver Transplanted Recipients and Healthy Donors, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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. Read more about this study
- Who is it for?
- Ages Up to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Liver Transplanted Recipients, Healthy Donors
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 57 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 250 pediatric living donor liver transplant recipients 250 corresponding adult living donors
Who may be able to join
- Children receiving a living donor liver transplant
- Adult living donors
Who cannot join
- No one
About this study
Official title: 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.
Read the 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.
- Keywords
- liver failure, liver malignancy, metabolic diseases, Pediatric liver transplanted recipients and their healthy donors
- Medical subject headings
- Liver Failure, Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and graft survival
Kaplan-Meier
Measured: 10 years
Secondary outcomes (1)
Portal vein complications
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Liver Transplanted RecipientsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond Reding, Md-PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124382
- Sponsor's protocol ID
- CHIRPEDMG2012
- Status last verified
- Apr 2014
- First submitted
- 24 Apr 2014
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Donor Liver Transplantation in Children: Surgical and Immunological Results in 250 Recipients at Université Catholique de Louvain.
- ClinicalTrials.gov ID
- NCT02124382
- Acronym / sponsor ID
- CHIRPEDMG2012
- Keywords
- liver failure, liver malignancy, metabolic diseases, Pediatric liver transplanted recipients and their healthy donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 250 pediatric living donor liver transplant recipients 250 corresponding adult living donors
Key inclusion criteria (2 listed)
- Children receiving a living donor liver transplant
- Adult living donors
Key exclusion criteria (1 listed)
- No one
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient and graft survival
Time frame: 10 years
Kaplan-Meier
1 secondary outcome
Portal vein complications
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Reding, Md-PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Liver Transplanted Recipients and Healthy Donors, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and graft survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.