EUCTR2020-000749-15-NL进行中（未招募）1 期
Resolution Enhancement by a Supplemental Open-Label Venoactive drug for Eight weeks in Deep Vein Thrombosis - The RESOLVE-DVT study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
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
- •?Adult, defined as = 18 years of age
- •?Objectively confirmed DVT by duplex echography
- •?Proximal DVT, defined as an iliofemoropopliteal venous thrombosis
- •?Acute DVT, defined as having symptoms for = 7 days at presentation
- •?Willing and able to give written consent
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •?Previous DVT
- •?Bilateral DVT, since the unaffected leg is needed as a reference for clinical signs
- •?Pre-existent chronic venous insufficiency (CEAP-criteria C = 3), since this influences thrombus resolution
- •?Active malignancy, inflammatory disease (e.g. rheumatoid arthritis) and/or immunosuppressive therapy, since this will influence circulating inflammatory biomarkers
- •?Current pregnancy, since knowledge on the teratogenicity of the IMP is too limited
- •?Indication for therapeutic thrombolysis, since this influences thrombus resolution
- •?Contra-indication for DOAC, including reduced kidney function (eGFR < 30 ml/min/1,73 m2) and underweight (<50kg)
研究者
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