Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 主要终点
- Percentage of participants suffering from pulmonary embolism
研究概览
简要总结
Temporary pacing via femoral vein is used widely in mainland China, because of its feasibility and simplicity. However, pulmonary embolism often occurred after the procedure. It is not known that whether there was any difference in incidence of pulmonary embolism between via different approaches. This randomized and multi-center study was designed to verify whether temporary pacing via subclavian vein has lower incidence than via femoral vein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years old or older
- •There is indication for temporary pacing
- •Patients agreed to participate in the clinical trial and sign a written informed consent
排除标准
- •History of pulmonary embolism or deep vein thrombosis
- •Devices existing in vein system
- •Patients who could not receive randomization
- •Severe coagulation disorder
- •Severe liver, kidney dysfunction
- •Mental diseases
- •Pregnancy
- •Patients investigators believed not suitable for enrollment
结局指标
主要结局
Percentage of participants suffering from pulmonary embolism
时间窗: 12 hours to 7 days after extraction of temporary pacing leads
次要结局
- Percentage of participants suffering from deep vein thrombosis(12 hours to 7 days after extraction of temporary pacing leads)
研究者
Minglong Chen
Vice Director of Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University; Professor of Medicine, Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University