NCT05571774招募中不适用
Construction of a Database for Thrombotic Thrombocytopenic Purpura
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年10月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of participants with stroke
研究概览
简要总结
Information about patients was collected by reviewing the Hitech case system and telephone and outpatient follow-up, and the case database was constructed by Epidata software. The sample size is expected to be 200 cases, the participating hospital is the First Affiliated Hospital of Soochow University, and the study time frame is from Oct 20, 2022, to Oct 20, 2027. The observation indexes of the study include the basic information of patients' age and gender and the clinical related data of thrombotic thrombocytopenic purpura.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with severe ADAMTS13 deficiency, defined as ADAMTS13 activity <10%, documented in the patient's medical history or at screening.
排除标准
- •The investigator considers the subject unable or unwilling to cooperate with the study procedures.
结局指标
主要结局
Number of participants with stroke
时间窗: 5 years from the time of entering the database.
Stroke was assessed with MRI imaging.
次要结局
未报告次要终点
研究者
研究点 (1)
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