Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Radial artery occlusion assessed by reverse Barbeau's test
研究概览
简要总结
In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug. Recently, ABS has been shown to produce local hemostasis by implementing topically after major arterial vessel injury. Reducing the compression time during patent hemostasis by facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in adjunct to short-time compression, compared to either short-time compression with conventional sterile gauzes or with a TR band after transradial diagnostic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •All consecutive patients undergoing transradial elective diagnostic coronary procedures between November 2016 and November 2017 at the catheterization laboratory of Acibadem University Kocaeli Hospital were considered to be enrolled in the study.
排除标准
- •The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.
研究组 & 干预措施
ABS
Ankaferd blood stopper
干预措施: ABS (Other)
CS
Conventional sterile gauze
干预措施: CS (Other)
TR BAND
Dedicated hemostatic device
干预措施: TR Band (Device)
结局指标
主要结局
Radial artery occlusion assessed by reverse Barbeau's test
时间窗: 24 hours
次要结局
- Bleeding(2 hours)
- Hematoma(24 hours)
研究者
Sevket Gorgulu
Prof. Dr.
Acibadem University