Immune Function Following Liver Transplantation

Completed

• Conditions: Liver Transplant; Complications

• Registration Number: NCT04302246
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Within a few decades, liver transplantation has become an effective treatment of end-stage liver diseases associated with high spontaneous mortality. However, the consequences of immediate transplants are frequently complicated by infective (nosocomial infection) and immunological complications (acute graft rejection) in up to 40 to 60% of liver transplanted patients. In order to ensure graft immunotolerance, immunosuppressive therapy based mainly on calcineurin inhibitors, is initiated soon after liver transplantation. Immunosuppressive therapy is intended to reduce the response of cytotoxic lymphocytes and NK cells. As a result, an important component of the immune response is blocked. In addition, function of the transplanted liver, which is a key organ for both immuno-inflammatory signalling and host defense against pathogens, is progressively restored post-operatively. Thus in this post-transplant period, there is a critical period where liver function is severly impaired and progressively get restaured. The aim of this study is to characterize the restauration of immune function in the early post-operative period and evaluate its correlation with occurence of infective or immunological complications.

Study Timeline

• Study Start: 2016-01-08
• Status Verified: 2019-12
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-03-06
• Last Update Submitted: 2020-03-06
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune functionnal profile	pre-operatively	quantitative monocytes mHLA-DR measurment