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临床试验/EUCTR2006-006823-38-DE
EUCTR2006-006823-38-DE进行中(未招募)1 期

D-Dimer guided oral anticoagulation therapy for secondary prevention after venous thrombosis - D-Dimer guided OAT

Rheinische Friedrichs-Wilhelms-Universität Bonn0 个研究点目标入组 300 人开始时间: 2007年5月11日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • To be enrolled in this study, patients must
  • have an objectively confirmed first episode of unprovoced VTE or of VTE during a minor transient risk factor. Minor transient risk factors include
  • - 6 weeks of estrogen therapy
  • - prolonged air travel (i. e. > 6 hours)
  • - pregnancy
  • - less marked leg injuries or immobilization without injury or surgical intervention
  • be scheduled to receive oral anticoagulant treatment for at least 3 months
  • be willing to be randomized
  • be willing to participate for the full duration of the study
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 180
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 120

排除标准

  • Exclusion criteria include
  • pregnancy or breast feeding
  • contraindications against OAT (i. e. intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke)
  • age < 18 years
  • presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i. e. antithrombin deficiency, hereditary PC deficiency)
  • poor patient compliance

研究者

发起方
Rheinische Friedrichs-Wilhelms-Universität Bonn

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