A Randomized Comparison of TR Band Hemostatic Compression Patterns After Transradial Coronary Intervention
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- RAO incidence
研究概览
简要总结
The purpose of the study is to investigate the protective effects of short term TR Band compression on transradial coronary occlusion after transradial coronary intervention.
详细描述
Radial artery occlusion (RAO), an infrequent but serious complication after transradial coronary intervention (TRI), prevents subsequent use of the same radial artery for coronary angiography and intervention. Comparing to the overseas counterparts, most Chinese medical workers put more emphasis on prevention of postoperative puncture site bleeding, so longer compression hemostasis time is applied but this prolonged compression may underestimate or even ignore an increasing risk of RAO. Therefore, this study intends to compare short term TR Band compression and the routine long term one on transradial coronary occlusion after transradial coronary intervention.
Participants allocated to the control group will receive a routine long term postoperative puncture site compression via TR Band. In control group, TR Band deflation is commenced at the 2nd hour with successive 5 mL air released at 2 hours intervals until the bladder was empty at the 6th hour, and the TR Band is removed at the 24th hour.
Participants allocated to the experimental group will receive a short term postoperative puncture site compression via TR Band. In experimental group, TR Band deflation is commenced at the 1st hour with 3 mL air released, and at the 2nd hour with 5ml, and at the 3rd hour with the remainder air in the bladder, and the TR Band is removed at the 12th hour.
At the 24th hour, RAO incidence, postoperative puncture site bleeding incidence and patient comfort level will be evaluated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older
- •Patients who received TRI for the first time
排除标准
- •Failure to puncture the radial artery in 1 attempt
- •Inaccessible radial arteries because of anatomic variations, such as hypoplastic radial arteries and radioulnar loop, which can be confirmed by radial artery angiography before the TRI
- •Patients who had previous radial procedure
- •Patients who were receiving IIb/IIIa receptor antagonist treatment
结局指标
主要结局
RAO incidence
时间窗: at the 24th hour post TRI
At the 24th hour post TRI, RAO will be diagnosed via ultrasonic sound and RAO incidence will be evaluated between two groups.
次要结局
- patient comfort level(at the 24th hour post TRI)
- postoperative puncture site bleeding incidence(within 24 hours after TRI)