INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis (INSIGHTS-SVT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 1,210
- 试验地点
- 1
- 主要终点
- Efficacy: incidence of venous thromboembolism (VTE) events
研究概览
简要总结
Superficial vein thrombosis (SVT) and venous thromboembolism (VTE) are related entities. Only in the last years a series of observational studies mainly conducted in France could show that ´isolated SVT´ (without concomitant deep vein thrombosis and/or pulmonary embolism) is in fact not a benign and spontaneously healing disease but bears a potential for severe thromboembolic complications once not treated adequately. INSIGHTS-SVT study aims at collecting representative data on the current management and outcomes of SVT in Germany under real-life conditions. It will document the implementation of the recently issued national SVT guidelines issued by the Society for Angiology (DGA) and the Society for Phlebology (DGP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Confirmed, acute, isolated SVT of the lower extremities
- •written informed consent
排除标准
- •SVT located at ≤ 3 cm of the saphenofemoral crossing (as such patients need to be treated for DVT)
- •Subjects unlikely to comply with the requirements of the protocol (due to cognitive and/or language limitations)
- •Patient(likely) not available for 1-year documentation
结局指标
主要结局
Efficacy: incidence of venous thromboembolism (VTE) events
时间窗: 3 months
VTE: composite of symptomatic pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), symptomatic recurrent superficial vein thrombosis (SVT), or symptomatic progression (extension) of SVT. This endpoint comprises symptomatic and asymptomatic VTE as reported by the treating physicians (usually diagnosed with compression ultrasonography or other appropriate methods). Events will be adjudicated.
Safety: incidence of major and clinically relevant bleeding events
时间窗: 3 months
Definition of bleeding events is based on American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (major bleedings) and the "Comparison of Arixtra in lower limb superficial vein thrombosis with placebo" (CALISTO) study definition (other bleedings), respectively. Events will be adjudicated.
次要结局
- New or recurrent cancer(3 months and 12 months)
- VTE rates in the subgroup of patients who underwent surgical procedures for SVT(3 months and 12 months)
- Diagnostic procedures for venous thromboembolism(through study completion, up to 12 months)
- Number of days spent in rehabilitation due to VTE(through study completion, up to 12 months)
- Incidence of lung embolism (LE)(12 months)
- Incidence of superficial vein thrombosis (SVT)(12 months)
- Death(3 months and 12 months)
- Incidence of deep vein thrombosis (DVT)(12 months)
- Health related quality of life on "VEnous Insufficiency Epidemiological and Economic Study" questionnaire(3 months)
- Number of days in hospital due to VTE(through study completion, up to 12 months)
- Numerical pain scale(through study completion, up to 12 months)
- Health-related quality of life on Euroquol 5 Dimensions questionnaire(3 months)
- Predictors of VTE during follow-up(through study completion, up to 12 months)