Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI：a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence early radial artery occlusion
研究概览
简要总结
The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic devices with or without quantitative pressure on radial arteries after coronary angiography (CAG) or percutaneous coronary intervention (PCI). The main questions aims to answer:
- What is the hemostatic effect of the patent hemostatic device with quantitative pressure after percutaneous coronary intervention?
- What are the precise hemostatic pressure and hemostatic time of the radial artery after CAG/PCI? Participants will be randomly assigned to the intervention group (IG) and control group (CG). The IG will use patent hemostatic device with quantitative pressure (PHDQP-Band, China) while the CG will use the conventional radial artery hemostatic device (TR-Band, Japan) without pressure monitoring.
The primary outcomes is incidence of 24h radial artery occlusion (24h RAO). Secondary outcomes include time to hemostasis, bleeding, hematoma, 30d radial artery occlusion (30d RAO), pain, hand swelling, numberness, pseudoaneurysm, and radial artery stenosis.
详细描述
The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic devices with or without quantitative pressure on radial arteries after percutaneous coronary intervention. The main questions aims to answer:
- What is the hemostatic effect of the patent hemostatic device after percutaneous coronary intervention?
- What are the precise hemostasis pressure and hemostasis time of the radial artery after percutaneous coronary intervention?
Participants will be randomly assigned to the intervention group (IG) and control group (CG).
For the participants assigned to the IG, the radial systolic pressure will be measured after TRA procedure. The PHD-Band with quantitative pressure ( WEGO Medical Products Group CO. LTD, China) will be placed at the entry site of the sheath. Connecting the hemostatic devices to the electric pneumatic machine with a connecting cable. After removing the radial sheath, the puncture site will be compressed by operator's hand. The PHD-Band with quantitative pressure will be inflated with specific pressure radial systolic pressure plus 10mmHg) and the hand will slowly release the pressure. If bleeding occurs, the PHD-Band will be deflated with 5-10mmHg automatically by parameter setting with the electric pneumatic machine until the bleeding stops. The PHD-Band will be deflated with20 mmHg, 40 mmHg of decreased pressure following 1h and 2h after the procedure. After 3 hours, the hemostatic pressure will be released to 45mmHg and the PHD-Band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated according to the previous pressure for another an hour until bleeding stops.
For the participants assigned to the CG, the TR-Band (Terumo Medical Corporation, Japan) will be placed at the entry site of the sheath after TRA procedure and inflated with 10 mL of air and the radial sheath will be removed with hand compression. Another 5 mL of air will be inflated and the operator's hand will slowly release the pressure. The TR band will be inflated until bleeding stopped with the maximum air volume no more than 18ml. The band will be deflated with 1 mL of air hourly for the following 2 hours after the procedure. After 3 hours, the band will be deflated with 4 mL of air first and then all volume of the rest air if no bleeding occurs and then the band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated with 1 mL of air until bleeding stops .
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 (Outcomes Assessor)
盲法说明
One of the primary outcome of radial artery occlusion will be assessed by masking the assessor. The data analyzers will also be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery; Positive Allen's test result; Willing to sign informed consent.
排除标准
- •Radial artery malformation； Chronic kidney disease with eGFR<30ml/min.1.73m2; Cirrhosis of the liver; Coagulation disfunction; Patients treated with IIb / IIIa receptor antagonist.
结局指标
主要结局
Incidence early radial artery occlusion
时间窗: Within 24 hours after CAG/PCI
RAO occurs within 24 hours after CAG/PCI
次要结局
- The degree of pain(baseline; 24 hours after PCI)
- Incidence of access site bleeding(Within 24 hours after CAG/PCI)
- Compression time(through hemostasis completion，estimated to be an average of 3~6hours)
- Incidence of hematoma(through hemostasis completion，estimated to be an average of 4~6hours)
- Incidence of 30d radial artery occlusion(Within 30 days after CAG/PCI)
- Hand swelling(baseline; 24 hours after PCI)
- pseudoaneurysm(Within 24 hours after PCI)
- numbness(baseline; 24 hours after PCI)