Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography
研究概览
简要总结
Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus within the venous system, mainly the lower limbs. The clot structure directly influences both its location, but also its progressive profile expansion material or regression and embolic migration.
Few data are available regarding the evolution of structural properties of thrombus after an acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how the thrombus responds to forces which it is subjected.
Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to study its evolutionary properties.
详细描述
The main objective of the study is to characterize the in vivo properties of elastographic thrombus in patients with proximal deep vein thrombosis (DVT), for quantitative elastography performed at D0, D7, D30.
The ability to analyze the structural properties of the thrombus should allow us to then correlate these properties to the evolving nature of the thrombus (embolic migration or not, recanalization or not), and the effect of different treatment on the evolution of the thrombus
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with proximal DVT, provoked or not, the symptomatology is less than 3d, with or without pulmonary embolism treated with heparin or oral anticoagulant
- •Signed informed consent
- •Patient affiliated to a social security scheme,
排除标准
- •pregnant or lactating
- •Life expectancy <1 month
- •Patient with distal DVT or asymptomatic DVT accidental discovery
- •Patient who underwent venous unclogging in acute phase
- •exclusion period in another study,
- •under administrative or judicial oversight, under guardianship
结局指标
主要结局
Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography
时间窗: Day 0, Day 7, Day 30
次要结局
- Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated(Day 0, Day 7, Day 30)
- Thrombus properties if provoked versus unprovoked thrombosis(Day 0, Day 7, Day 30)
- Correlation of the thrombus in vivo properties to the thrombin generation capacity and viscoelastic properties tested ex vivo by rotational thromboelastometry(Day 0, Day 7, Day 30)