Comparison Between Compressive Elastic Dressing and Hemostatic TR Band Following Cardiac Intervention Utilizing the Radial Technique: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Compression "hemostasis" time
研究概览
简要总结
Radial approach is widely established in cardiac diagnostic and therapeutic treatments. It has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. It also offers better comfort to patients through early mobility and lowers hospital expenses.
Previously, there were no specific devices for radial artery hemostasis. Many different types of dressings were used in various hospitals with no standardization. This raises the question of whether specific devices surpass dressings in terms of patient comfort, time required to maintain hemostasis, and vascular complications.
The primary goal of this study was to examine the effectiveness of compression dressings and hemostatic wristbands on patients undergoing cardiac procedures via radial approach in terms of patient comfort, time required to maintain hemostasis, and vascular problems.
The hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized in one group, while compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, was used in the other.
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
- Single (Outcomes Assessor)
盲法说明
Patients enrolled to the study were randomized into TR Band or compressive dressing groups. Care providers operated on patients and investigators collected their data during and after the operation. The independent variable - Hemostasis technique (TR Band or compressive dressing ) - was coded into X or Z groups, then data was sent to the outcomes assessor.
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
- •Patients who agree to participate in the study and sign the consent form.
- •Patients with an indication for coronary catheterization
- •Clinically stable patients
- •Patients with palpable pulses on at least one of the radial arteries.
排除标准
- •Patients who are hemodynamically unstable (systolic blood pressure less 90mmhg)
- •Patients with radial AV shunt for hemodialysis
- •Patients with previous CABG using radial artery
- •Patients with Renaud phenomenon or lymphedema
- •Patients who had vascular problems at the puncture site before the hemostasis process started.
- •Failure to obtain radial access
结局指标
主要结局
Compression "hemostasis" time
时间窗: Up to 240 minutes after placement
The time from the placement of the hemostatic Wristband or Compressive dressing until its removal (when there's no blood oozing after removal), measured by minutes.
Number of patient with Hematoma and Grade of hematoma
时间窗: Within 24 hours after the procedure
It is defined by EASY hematoma scale.
次要结局
- Post-procedural pain(Within 24 hours after the procedure)
- Number of patient with Radial artery occlusion(Within 24 hours after the procedure)
- Ischemic changes to the hand(Within 24 hours after the procedure)
- Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction(Within 24 hrs)
- Number of patient with Radial Artery Occlusion on follow up(After 4 weeks of the procedure.)
研究者
Yunis Daralammouri
Assistant Professor
An-Najah National University