Graduated Compression Stockings (GCS) for Prevention of Venous Thromboembolism in Patients Who Have Major Surgery: Pilot Study Assessing Feasibility of Adding This Evaluation to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objectively confirmed symptomatic major venous thromboembolism
研究概览
简要总结
This is a pilot substudy to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2), to assess the feasibility of adding graduated compression stockings (GCS) to POISE-2 as an intervention.
详细描述
Objective
To determine if thigh-level graduated compression stockings (below-knee graduated compression stockings may be used if thigh level graduated compression stockings are not feasible, such as after knee surgery), started before surgery and worn until discharge and for a minimum of 10 days (whichever is longer), reduce symptomatic venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) in the 30 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomized to PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)
排除标准
- •Unable to wear a graduated compression stockings on a leg that has been operated on (e.g., below knee skin grafting)
- •Leg has not been operated on and graduated compression stockings cannot be worn on either leg (e.g. bilateral leg amputations or skin ulceration, allergy to material in the graduated compression stockings)
- •Graduated compression stockings cannot be fitted because the patient's legs are too big, or too small (not compatible with manufacturer's recommendations)
- •The responsible physician/nurse judges that graduated compression stockings are contraindicated because of: i) decreased circulation in the legs as evidenced by very pale, cyanotic, or gangrenous conditions; or ii) risk of stocking-induced skin necrosis due to an established sensory neuropathy with numbness to touch.
结局指标
主要结局
Objectively confirmed symptomatic major venous thromboembolism
时间窗: 30 days
The primary outcome to assess efficacy will be a comparison of the proportion of patients who have objectively confirmed symptomatic major venous thromboembolism (defined as proximal deep vein thrombosis or pulmonary embolism) within 30 days of randomization (includes episodes that are diagnosed in response to symptoms reported at the 30 day assessment).
次要结局
- Any symptomatic venous thromboembolism or pulmonary embolism(30 days)
- Major venous thromboembolism and death(30 Days)
- Safety Outcomes(30 Days)