NCT03238443已完成不适用
Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Prevalence DSA positivity (or anti-HLA).
研究概览
简要总结
The study is a prospective observational mono center study
Primary objective :
Study the anti-HLA antibodies frequency preformed before liver transplantation and the kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver transplantation.
Secondary objective :
-
Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)
-
Impact of DSA on:
-
Graft and patients survivals
-
Onset of allograft rejection (acute, late-onset, chronic)
-
Unexplained liver graft dysfunction
-
Unexplained liver enzymes abnormalities
-
Liver fibrosis development (liver stiffness study using fibroscan©)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver transplanted patients older than 18, transplanted in Lille University Hospital.
- •Written consent by the patient or his/her legal representative (especially patient with hepatic encephalopathy).
- •Patients with health insurance
排除标准
- •Minor patients.
- •Pregnant women or during lactation.
- •Patient under curatorship.
结局指标
主要结局
Prevalence DSA positivity (or anti-HLA).
时间窗: At baseline
The positivity is defined as a fluorescence ≥ 1000.
次要结局
- Presence of C1q binding-complement anti-HLA antibodies(at 3 months, 1 year and 2 years after transplantation)
- Fluorescence quantification(at 3 months, 1 year and 2 years after transplantation)
研究者
研究点 (1)
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