The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 20
- 主要终点
- Incidence of PTS and PTS severity
研究概览
简要总结
The purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic Syndrome (PTS) during the 2 years of follow up in the SOX Trial.
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) for two years following DVT could be helpful in preventing or delaying onset of PTS at three years, however data supporting this is limited.
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
- •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 PTS and PTS severity
时间窗: 3 year follow up
次要结局
未报告次要终点
研究者
Dr. Susan Kahn
SOX Trial Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital