Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Patent Hemostasis: OPEN-Radial Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Number of Patients Who Achieved Patent Hemostasis
研究概览
简要总结
In patients referred for cardiac catheterization to be performed using transradial access, a randomized comparison will be performed with the primary endpoint of patency of radial artery at the time of application of hemostatic compression band. The single radial only TR-Band (Terumo, Japan) will be compared to the dual balloon Vasoband (Vasoinnovations, USA) capable of ipsilateral ulnar artery compression.
详细描述
Introduction:
TRA is increasing in utilization across the world due to its established benefits of reduction in access site complications, cost, and increase in patient comfort (1). The most common structural consequence of TRA is radial artery occlusion (RAO). It occurs in 2-10% of patients undergoing TRA (2). Several pharmacologic as well as non-pharmacologic practices have been associated with RAO. Maintaining a hardware profile smaller than the inner diameter of radial artery has been associated with better radial artery patency rates after the procedure (3). Use of unfractionated heparin and other parenteral anticoagulants administered during the procedure has also been associated with reduction in RAO, with a dose-dependent effect with better reduction with higher doses of heparin (4,5).
One of the most effective intervention for reduction of RAO is avoidance of flow cessation in radial artery during hemostatic compression (6). This technique, called "patent hemostasis", has been shown to unequivocally and sizably reduce the incidence of RAO. In patients with small diameter radial arteries as well as low blood pressures, the ability to achieve and maintain patent hemostasis has been observed to be lower than those otherwise. In view of the co-dominant nature of forearm arterial circulation, the radial and ulnar arteries are interdependent and compression of ipsilateral ulnar artery has been shown to increase flow as well as peak flow velocity in the radial artery (7). Ipsilateral ulnar artery compression during hemostatic compression of a punctured radial artery, has been shown to sizably and significantly reduce the incidence of RAO compared to patent hemostasis (8). Randomized and observational datasets utilizing this technique published so far have been using two devices to achieve radial and ulnar compression, with difficult ergonomics leading to frequent dislodgment of ulnar compression during the radial artery hemostatic process.
The investigators intend to study the comparative efficacy of the first dedicated dual compression device in achieving patent hemostasis compared to the current popular radial artery compression device.
Patients and Methods:
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for cardiac catheterization undergoing transradial access
排除标准
- •Previous ipsilateral radial artery cannulation, oral systemic anticoagulation therapy, thrombolytic therapy in the previous 7 days.
结局指标
主要结局
Number of Patients Who Achieved Patent Hemostasis
时间窗: 0-15 minutes
Patent hemostasis achievement at 0-15 minutes after onset of radial artery hemostatic compression
次要结局
- Number of Participants With Radial Artery Occlusion One Hour After Removal of Hemostatic Compression(0-60 minutes)