Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients: a Multicentre Cluster Randomised Controlled Trial (PETS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21,472
- 试验地点
- 10
- 主要终点
- The rate of symptomatic VTE within 90 days
研究概览
简要总结
Hospital acquired thrombosis describes blood clots that form in the legs and lungs after someone is treated in hospital. Clots in the leg can cause swelling, pain and other problems. If a clot in the leg travels to the lungs, it may be life threatening. Having surgery increases the risk of developing blood clots.
People having short-stay surgery (who either go home the same day or who stay overnight but go home shortly afterwards) are at a much lower risk of developing a blood clot than those who stay in hospital for longer. These low-risk people are often given elastic stockings (which squeeze the leg muscles) to reduce the chance of a blood clot.
The risks of wearing the stockings are low but they can be uncomfortable. In the UK, there are over a million short stay surgeries performed each year and most of these people are given elastic stockings to wear. Stockings cost the NHS a lot of money and it remains unknown if they work.
This study will investigate if it is worthwhile to continue using elastic stockings in people having surgery where the risk of developing blood clots is low. Adults (over 18-years) who are at low risk of developing blood clots (assessed using a nationally recognised tool) will be included.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18-59 years of age) scheduled to undergo a surgical procedure with a hospital stay <48 hours
- •Individuals assessed as being at low-risk of developing VTE as per the DHRA Tool (i.e. no assessed thrombosis risk factors / scoring 0)
排除标准
- •Individuals with a contraindication to GCS
- •Individuals assessed as being at moderate or high-risk of VTE as per the DHRA tool
- •Individuals requiring therapeutic anticoagulation
- •Individuals with thrombophilia/ thrombogenic disorder
- •Individuals with a previous history of VTE
- •Individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery
- •Individuals requiring extended thromboprophylaxis beyond discharge
- •Female patients of childbearing age who have a positive pregnancy test
- •Individuals with lower limb immobilisation
- •Inability to provide informed consent
结局指标
主要结局
The rate of symptomatic VTE within 90 days
时间窗: 90-days
The rate of symptomatic VTE for surgical patients undergoing short-stay procedures assessed as being at low-risk of VTE
次要结局
- Quality of Life(7 and 90-days)
- Health Economic Outcome(2 years)
- Adverse events related to GCS(7-days)
- Mortality(90-days)