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临床试验/NCT01444079
NCT01444079已完成不适用

Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

Yonsei University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
incidence of acute rejection

研究概览

简要总结

Liver is an organ that is well-known for its immune tolerant capacity. However, there were still controversial issues about the impact of immunologic challenge after liver transplantation on the graft function. Different results of graft function affected by immunologic factors such as pre-transplant panel reactive antibody (PRA) status, pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor specific antibody (DSA) has been reported according to individual institutes. There was no trial for presenting anti-donor lymphocyte antibody change after liver transplantation.

The investigators designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the investigators will find aspects of anti-donor lymphocyte antibody change after liver transplantation.

详细描述

Study Design: Target study population is forty patients who will undergo liver transplantation for 1 year in YUHS. Pediatric and early mortality cases will be excluded. Blood sample will be collected at pre-transplant period, post-transplant 7, 14, 21 day, 3 month and 6 month.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Liver recipients who undergo liver transplantation between Mar, 2011 and Feb, 2012
  • Patients who can be followed for more than 3 months after transplantation

排除标准

  • Age under 20 years
  • Multi-organ transplantation
  • Not agree with informed consent
  • Patient who had plant to be transferred to other country or center

结局指标

主要结局

incidence of acute rejection

时间窗: Time point when patients are diagnosed acute rejection

We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.

次要结局

  • correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival(at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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