Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Bleeding Requiring Intervention After Initial Hemostasis Achieved
研究概览
简要总结
The purpose of this pilot study was to compare two devices and three methods for achieving hemostasis after a transradial angiogram while assessing vascular complications and time endpoints. The heart has traditionally been accessed through the femoral artery. However, in the last 20 years, the radial artery has gained more popularity among physicians and patients, thereby offering an alternative to the femoral approach. Various methods of applying compression to the radial puncture site have been used, but no research has been done to show what best practice is. In this case, best practice would be the most effective way of getting hemostasis while limiting complications and ensuring the efficient use of nursing and medical resources. It is hypothesized that statistically significant differences are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as compared with the control Terumo group, without increasing vascular complications.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nonemergent
- •outpatient
排除标准
- •inpatients
- •emergency patients
- •booked angioplasty patients
- •cognitive impairment
- •those in whom the approach was initiated but aborted due to inability to puncture the radial artery
研究组 & 干预措施
Terumo Control
干预措施: Terumo TR wristband (Device)
Terumo Fast Release
干预措施: Terumo TR wristband (Device)
Clo-Sur P.A.D.
干预措施: Clo-Sur-P.A.D. (Device)
结局指标
主要结局
Bleeding Requiring Intervention After Initial Hemostasis Achieved
时间窗: Assessed after initial hemostasis achieved
Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved
Bleeding Requiring Intervention Post-CATH Day 1
时间窗: Assessed post-CATH Day 1
Number of Participants with Bleeding Requiring Intervention post-CATH Day 1
次要结局
- Hematoma or Bruising Post-CATH Day 1(Assessed post-CATH day 1.)
- Hematoma or Bruising at Discharge(Assessed at discharge)
- Time to Discharge(Assessed on day of angiogram.)
- Radial Artery Occlusion Post-CATH(Assessed via plethysmography and palpation post-CATH)
- Radial Artery Occlusion Post-CATH Day 1(Assessed via plethysmography and palpation post-CATH day 1.)