The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 806
- 试验地点
- 50
- 主要终点
- Incidence of Post-thrombotic Syndrome (PTS)
研究概览
简要总结
The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome in patients with symptomatic proximal deep venous thrombosis.
详细描述
The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) could be helpful in preventing PTS, however data on their effectiveness are scarce and conflicting.
Comparison(s): Knee-length, 30-40 mm Hg (Class II), graduated ECS worn on the DVT-affected leg daily for 2 years compared to knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily for 2 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
- •Who have no contraindications to standard treatment with heparin and/or warfarin, and
- •Who provide informed consent to participate
排除标准
- •Contraindication to compression stockings
- •Limited lifespan (estimated < 6 months)
- •Geographic inaccessibility preventing return for follow-up visits
- •Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
- •Treatment of acute DVT with thrombolytic agents
结局指标
主要结局
Incidence of Post-thrombotic Syndrome (PTS)
时间窗: During 2-year follow up
次要结局
- Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding(During 2-year follow up)
- Severity of PTS, Including Incidence of Venous Ulcer(6-24 months.)
- Quality of Life(24 months)
研究者
Dr. Susan Kahn
SOX Trial Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital