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临床试验/NCT01112202
NCT01112202已完成不适用

Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1

研究概览

简要总结

Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Pradaxa® on different coagulation parameters.

详细描述

This mono-centric, open-label study is undertaken to validate the effects of Dabigatran on coagulation parameters in plasma samples of 70 patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d. Plasma samples are obtained by blood collection before, after 2 hours and after 12-14 hours after Dabigatran dosing in steady state (on 3rd - 5th day).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Age > 18 y

排除标准

  • Hemorrhagic disorder
  • Liver disease
  • Severe renal impairment

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other

研究点 (1)

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