Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 865
- 试验地点
- 27
- 主要终点
- The occurrence of PTS at 24 months after the event of acute DVT
研究概览
简要总结
In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ECS therapy for individual patients should be. ECS therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial costs could be saved by tailoring therapy to individual needs and as a result the quality of life for individual patients can be expected to improve.
This study aims to assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs.
ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy, following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The primary outcome is the percentage of patients with PTS at two year follow-up.
This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
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
- •Legal age (18 yrs)
- •Informed consent
- •Acute objectively documented DVT of the leg
- •Adequate anticoagulation
排除标准
- •Previous DVT in the affected leg
- •Recurrent DVT in the first 6 months following inclusion
- •Preexistent venous insufficiency (skin signs C4-C6 on CEAP score or requiring ECS therapy)
- •Contraindication for elastic compression therapy (arterial insufficiency)
- •Active thrombolysis
- •Life expectancy < 6 months
研究组 & 干预措施
Intervention: individually tailored ECS
Individually tailored duration of elastic compression therapy, based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months.
干预措施: Individually tailored duration of elastic compression therapy (Device)
Control: ECS 24 months
Elastic compression therapy with a standard duration of 24 months
干预措施: Elastic compression therapy with a standard duration of 24 months (Device)
结局指标
主要结局
The occurrence of PTS at 24 months after the event of acute DVT
时间窗: At 24 months after the event of the acute DVT
次要结局
- Mortality due to venous thrombosis(24 months)
- Costs(3, 6, 12, 24 months)
- Health Related Quality of Life (HRQOL)(Baseline, 3, 6, 12 and 24 months)
- Recurrent venous thrombosis(24 months)
- Patient Preferences(baseline, 24 months)