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临床试验/NCT04302246
NCT04302246已完成不适用

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

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 61 人开始时间: 2016年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
主要终点
Immune functionnal profile

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Immune functionnal profile

时间窗: pre-operatively

quantitative monocytes mHLA-DR measurment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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