NCT04302246

Brief Summary

Post-operative care following liver transplantation is characterized by a high incidence of infective and immunological complications. Restauration of liver function following liver transplantation is progressive and characterize a period of immuno-infective vulnerability. The purpose of this study is to characterize the early post-operative immune function in children after liver transplantation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

December 1, 2019

Enrollment Period

3.9 years

First QC Date

December 18, 2019

Last Update Submit

March 6, 2020

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

  • Immune functionnal profile

    quantitative monocytes mHLA-DR measurment

    pre-operatively

Interventions

Biological testing on sequential blood sampleGENETIC

Biological characterization of various immune function and blood circulating leukocytes phenotyping before liver transplantation and therafter at day-3, -7, -14 postoperatively and if septic complication occurs.

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Child admitted for liver transplantation

You may qualify if:

  • Child under 18 admitted for liver transplantation
  • Signature of consent by the two holders of parental authority.
  • Informing children as far as their age and condition allow.
  • Affiliation to a social protection

You may not qualify if:

  • Children under 6 kg
  • Children transplanted for primary graft dysfunction
  • Children scheduled for liver-kidney transplants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

The biological collection will include plasma, RNA and DNA samples, which will be stored at - 20 ° C for sera, and - 40 ° C for blood RNA and liver biopsy (stabilized in a buffer containing RNase inhibitors) and DNA (stabilized in a buffer containing DNase inhibitors)

Study Officials

  • Pierre TISSIERES

    Assistance Publique des Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 18, 2019

First Posted

March 10, 2020

Study Start

January 8, 2016

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

March 10, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share