Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Bleeding
研究概览
简要总结
In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Age 18 years and older
- •Have an acceptable Barbeau test (i.e. type A through C)
- •Have acceptable coagulation parameters (based on PT, INR, platelet count, and appropriate pre-procedural management of anticoagulants, See Table 1)
- •The caliber of the left radial artery based on a pre-procedure sonographic evaluation will need to be greater than or equal to 1.6 mm.
- •The appropriate pre-procedural management of anticoagulants is based on the consensus guidelines established by Patel et al
- •INR less than 1.5
- •Platelet count greater than 50,000 platelet/uL
- •Prothrombin time less than 15 seconds
排除标准
- •If there is an unacceptable risk of bleeding diathesis, or
- •If he or she is not a suitable candidate for transradial access based on a Barbeau test type D or a diameter of the left radial artery less than 1.6 mm.
研究组 & 干预措施
Group A
干预措施: TR Band 60MIN (Device)
Group B
干预措施: TR Band 120MIN (Device)
结局指标
主要结局
Percentage of Participants With Bleeding
时间窗: 30 days post procedure
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Left Radial Artery Occlusion
时间窗: 30 days post procedure
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Percentage of Participants With Bleeding
时间窗: an average of 12 hours post procedure
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
次要结局
未报告次要终点