NCT04374799招募中3 期
A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 1,623 人开始时间: 2020年10月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,623
- 试验地点
- 2
- 主要终点
- radial artery occlusion
研究概览
简要总结
Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.
详细描述
Patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU), high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.
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
- Triple (Participant, Investigator, 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
- •diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation
排除标准
- •abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation
研究组 & 干预措施
Low dose heparin
Active Comparator
heparin (25 IU/Kg -maximal dose 3,000 IU)
干预措施: Heparin (Drug)
High dose heparin
Active Comparator
heparin 50 IU/kg -maximal dose 5,000 IU
干预措施: Heparin (Drug)
Placebo
Placebo Comparator
Normal saline 0.9%.
干预措施: Placebos (Drug)
结局指标
主要结局
radial artery occlusion
时间窗: 1 hour
by ultrasound
次要结局
- access site bleeding(1 hour)
- time to discharge(1 day)
- access site complications(1 day)
- wrist band duration(3 hours)
- non access site bleeding(1 day)
- Hematoma> 5 cm(one hour post procedure)
研究者
研究点 (2)
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