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临床试验/NCT03972839
NCT03972839已完成不适用

Comparison of Two D-Dimers Dosing Techniques : LIATEST DDI PLUS (STAGO) Versus VIDAS D-DIMERS (BIOMERIEUX)

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 3,027 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,027
试验地点
1
主要终点
Biomerieux D-Dimer level

研究概览

简要总结

Study of the possibility of substitution of the automated STAGO D-Dimers method with the semi-automated VIDAS method, which is more expensive, longer to implement and requires the use of a dedicated automaton.

详细描述

To compare D-Dimer assay techniques in the exclusion of VTE (Thromboembolic Venous Disease):• BIOMERIEUX: D-Dimers VIDAS (considered as reference technique)• STAGO: D-Di PlusOn a population of patients recruited in Brest for a period of 1 year: patients for whom a dosage of VIDAS D-dimers is prescribed (approximately 3700 patients)

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

入选标准

  • Patients for whom a dosage of D-Dimers VIDAS is prescribed in the context of a suspicion of VTE at Brest CHRU.
  • No opposition formulated.

排除标准

  • Curative dose anticoagulant treatment whatever the indication,
  • Pregnancy in progress,
  • Follow-up at 3 months not possible,
  • Patient refusing to participate

结局指标

主要结局

Biomerieux D-Dimer level

时间窗: at the inclusion

quantification of Biomerieux D-Dimer level (VIDAS)

Stago D-Dimer level

时间窗: at the inclusion

quantification of Biomerieux D-Dimer level (STAGO)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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