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临床试验/NCT01571349
NCT01571349已完成不适用

Hemostasis in Patients With Idiopathic Thrombocytopenic Purpura

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012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
20
试验地点
1
主要终点
maximum clot formation

研究概览

简要总结

The investigators are trying to investigate the coagulation status of idiopathic (immune) thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von Willebrand factor level, thromboelastography.

详细描述

In patients with chronic coagulation disorder, laboratory model and clinical data have shown evidence for a rebalanced hemostasis. Previous study showed that the platelet count may not predict the risk of bleeding since the platelet count is not an indicator of platelet function. Thromboelastography may be the choice of investigation when platelet function is in question especially in patients with idiopathic (immune) thrombocytopenic purpura (ITP). Previous study have shown that maximum clot formation is the most important thromboelastography parameter in predicting bleeding in ITP patients that makes thromboelastography superior to other hemostatic tests. The investigators are trying to evaluate the rebalanced hemostasis in patients with ITP by comparing the value of platelet count, von Willebrand factor antigen level, and thromboelastography parameters.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Those who visits the outpatients clinic of Samsung Medical Center with a diagnosis of idiopathic (immune) thrombocytopenic purpura (ITP)between March, 2012 and February,
  • Those with age between 20 and 70 yrs old

排除标准

  • Those with other causes of thrombocytopenia other than ITP

结局指标

主要结局

maximum clot formation

时间窗: within 3 hour of blood sampling

thromboelastography parameters performed within 3 hours of blood sampling

次要结局

  • platelet count(within 1 hours of blood sampling)
  • Coagulation battery results(within 1 hour after blood sampling)
  • von Willebrand factor antigen(within 3 hours of blood sample)
  • clotting time(within 3 hours of blood sampling)
  • alpha angle(within 3 hours of blood sample)
  • A10, A15, A20, A25(within 3 hours of blood sampling)
  • LY 60(within 3 hours of blood sampling)
  • CLI(within 3 hours of blood sampling)
  • Maximum lysis(within 3 hours of blood sampling)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaab Soo Kim

Professor

Samsung Medical Center

研究点 (1)

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