Therapeutic Orientation Test in Thrombotic Microangiopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 57
- 主要终点
- Therapeutic orientation test sensitivity
研究概览
简要总结
Haemolytic and Uraemic Syndrome (HUS) is a serious disease requiring rapid diagnosis and management. The atypical HUS diagnosis has been greatly improved by anti-CS antibody (Eculizumab) wich block alternative complement pathway activation. To rise treatment success, Eculizumab introduction should be as early as possible. In some secondary HUS (infection, drugs…) complement is also involved as "second-hit".
To date, there is no tool to confirm complement involvement in a HUS at diagnosis stage. This study suggest to evaluate a therapeutic orientation test, in order to determine the complement implication in HUS diagnosis. The test evaluates the complement deposits on endothelial cell surface in vitro, compared to a normal human serum.
In order to determine the test performance, first the positive or negative results will be compared to the HUS clinical evolution, treated or not by the clinician with Eculizumab. Second, the test results will be compared to the presence of alternative complement pathway regulation abnormalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mechanic haemolytic anemia, undetectable haptoglobin, LDH>1.5*LNS
- •thrombopenia
- •acute kidney injury TMA on native kidney or in post-transplantation.
排除标准
- •DIVC patients
- •plasma exchange during 1 month before sample collection
- •treatment by Eculizumab before sample collection
- •no consent
- •not beneficiary of a social security
- •pregnancy or breastfeeding
- •patient Under guardianship
研究组 & 干预措施
Patients with Thrombotic micro-angiopathy
干预措施: Therapeutic orientation test for TMA (Diagnostic Test)
结局指标
主要结局
Therapeutic orientation test sensitivity
时间窗: Through study completion, an average of 3 years.
The proportion of patients testing positive among those receiving a relevant Eculizumab treatment ( TMA resolution with treatment or presence of abnormalities in alternative complement pathway.
Therapeutic orientation test specificity
时间窗: Through study completion, an average of 3 years.
The proportion of patients testing negative among patients who did not receive Eculizumab treatment.(TMA resolution without treatment or therapeutic failure with Eculizumab).
次要结局
- Untreated test positive patients(Through study completion, an average of 3 years.)