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临床试验/EUCTR2012-001505-24-ES
EUCTR2012-001505-24-ES进行中(未招募)1 期

Highlow studyLow-molecular-weight heparin to prevent recurrent VTE in pregnancy: a randomized controlled trial of two doses - Highlow study

Academic Medical Center (AMC)0 个研究点目标入组 850 人开始时间: 2018年3月12日最近更新:
适应症
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
850

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
Female

入选标准

  • -Age = 18 years
  • -Pregnancy confirmed by urinary pregnancy test, gestational age < 14 weeks since first day of last menstrual period
  • -Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 850
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor
  • -Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy)
  • -Inability to provide informed consent
  • -Any contraindication listed in the local labelling of LMWH

研究者

发起方
Academic Medical Center (AMC)

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