Effect of Two Compression Devices on the Occurrence of Artery Occlusion After Transradial Cardiac Catheterization: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Radial artery occlusion evaluated using Barbeau's test
研究概览
简要总结
Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.
详细描述
Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.
Interventions: Radial hemostasis with TerumoBand® and Radial hemostasis with a standardized compressive dressing
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients submitted to elective or urgent coronary catheterization who presented with a A, B or C curve on oximetry test before the procedure
排除标准
- •Inability to understand the study and sign the informed consent form
研究组 & 干预措施
Control group
Standardized compressive dressing
干预措施: Standardized compressive dressing (Device)
Intervention group
Hemostasis with TerumoBand®
干预措施: Hemostasis with TerumoBand® (Device)
结局指标
主要结局
Radial artery occlusion evaluated using Barbeau's test
时间窗: up to 3 hours
test immediately after hemostasis compression device withdrawal
次要结局
- Vascular complications(up to 3 hours)
- Radial access site pain(up to 3 hours)