A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- any episode of VTE
研究概览
简要总结
The aim of the study is to make a validation of Caprini score in patients undergoing varicose veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT, radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit from prophylactic anticoagulation.
详细描述
A prospective cohort study based on the platform of Ongoing Registry of Treatment of Chronic Venous Diseases (NCT03035747). The study will enrol adult patients undergoing any kind of varicose veins surgery with and without any prophylaxis. The patients should be examined for venous thromboembolic complications during 2-4 weeks after the procedure with mandatory duplex ultrasound.
The study will provide following information:
- the rate of asymptomatic DVT after varicose veins surgery
- the rate of symptomatic VTE after varicose veins surgery
- the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation
- the ability of Caprini scores to predict VTE after varicose veins surgery
- identification of patients with high risk of VTE who will benefit from prophylaxis, especially with anticoagulation
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
- •age over 18 years
- •any kind of varicose vein surgery
- •follow up for 4 weeks after the procedure
- •examination for VTE at 2-4 weeks after the procedure, including duplex ultrasound
排除标准
- •- lost for follow-up during 4 weeks
结局指标
主要结局
any episode of VTE
时间窗: 0-4 weeks after procedure
symptomatic or asymptomatic, confirmed by instrumental diagnostics
次要结局
- symptomatic deep vein thrombosis(0-4 weeks after procedure)
- symptomatic pulmonary embolism(0-4 weeks after procedure)
- asymtomatic deep vein thrombosis(2-4 weeks after procedure)
- endovenous thermal-induced thrombosis(0-4 weeks after procedure)
- death for any reason(0-4 weeks after procedure)
- major bleeding(0-4 weeks after procedure)
- clinicaly relevant bleeding(0-4 weeks after procedure)
研究者
Kirill Lobastov
Associated Professor
Pirogov Russian National Research Medical University