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Completed

NCT Number: NCT04302246

Immune Function Following Liver Transplantation

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.

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological testing on sequential blood sample

Genetic

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.

Primary outcomes

  1. Immune functionnal profile

    Time frame: pre-operatively

    quantitative monocytes mHLA-DR measurment

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Immune Functional Profile as Predictor of Infective Complications Following Pediatric Liver Transplantation

Acronym: SEPTIFOIE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2020
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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