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临床试验/NCT04539301
NCT04539301招募中不适用

Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,100
试验地点
1
主要终点
Agreement between measured and estimated levels of each factor-Xa inhibitor

研究概览

简要总结

Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay. The investigators aimed at assessing whether the widely used heparin anti-Xa assay can quantify the apixaban, rivaroxaban, fondaparinux and danaparoid levels.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Agreement between measured and estimated levels of each factor-Xa inhibitor

时间窗: 2 years

An estimated anticoagulant level between 80 and 120% of the value obtained by the reference method ("specific assay") will be deemed clinically acceptable, i.e. the patient's management would have been the same.

次要结局

  • Evaluation of the performance of the estimated anticoagulant level method by an inter-laboratory comparison program(2 years)
  • Cost comparison (estimated anticoagulant level method versus specific dosage)(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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