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临床试验/NCT00818688
NCT00818688已完成不适用

Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

Centre Hospitalier Universitaire de Saint Etienne5 个研究点 分布在 1 个国家目标入组 844 人开始时间: 2005年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
844
试验地点
5
主要终点
Incidence of confirmed venous thromboembolism at three months.

研究概览

简要总结

We performed a national cross-sectional and prospective large epidemiological cohort study in patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long documented by compression ultrasonography. Follow-up was three months. All events were adjudicated by a central committee.

详细描述

Between March 2005 and October 2006, 844 patients (median age [range]: 65 [18-98] years; 547 women) were included. At inclusion, confirmed deep-vein thrombosis and/or symptomatic pulmonary embolism was associated with ST in 24.9% (n=210) of patients. Among the 600 patients with isolated ST (i.e. without deep-vein thrombosis or pulmonary embolism at inclusion), 10.4% (n=56) developed venous thromboembolic complications at three months, including the following symptomatic events: pulmonary embolism (0.4%, n=2), deep-vein thrombosis (2.8%, n=15), extension of ST (3.1%, n=17) and recurrence of ST (1.9%, n=10). These complications occurred despite the use of various anticoagulant strategies in 90.5% (n=540) of patients; four independent risk factors increased the risk of these complications: male sex, cardiac or respiratory insufficiency, history of deep-vein thrombosis or pulmonary embolism and no history of varicose veins.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all consecutive patients aged 18 years or over, with a symptomatic ST of the lower limbs at least 5 cm long on compression ultrasonography.

排除标准

  • patients who had undergone surgery under general or loco-regional anaesthesia in the previous 10 days, those in whom ST had occurred after sclerotherapy within the previous 30 days and those whose follow-up was not considered to be feasible were ineligible

结局指标

主要结局

Incidence of confirmed venous thromboembolism at three months.

时间窗: 3 months

次要结局

  • Overall mortality at three months(3 months)

研究者

研究点 (5)

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