跳至主要内容
临床试验/NCT02371044
NCT02371044已完成不适用

Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1

University Hospital Tuebingen0 个研究点目标入组 60 人开始时间: 2013年5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
60
主要终点
Effect/Correlation of direct oral anticoagulants (DOAC) on CoaguChek point-of-care testing (POCT) result

研究概览

简要总结

The investigators study aims to test the correlation between the CoaguChek point-of-care testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke 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

  • Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
  • Age ≥ 18 years

排除标准

  • Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation
  • Low-molecular weight heparin ≤ 24 hours
  • Unfractionated heparin ≤ 12 hours
  • Abnormal coagulation values at baseline (Quick < 70% or activated thromboplastin time (aPTT) > 40sec.)
  • History of coagulopathy

结局指标

主要结局

Effect/Correlation of direct oral anticoagulants (DOAC) on CoaguChek point-of-care testing (POCT) result

时间窗: 24 hours

DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry

次要结局

  • Diagnostic accuracy of the CoaguChek POCT to rule out or detect relevant DOAC levels(24h)
  • Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay(24h)

研究者

申办方类型
Other
责任方
Sponsor

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