High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion Forearm Artery Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Radial artery occlusion
研究概览
简要总结
This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Patients are randomized before diagnostic catheterization to receive intravenously either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged usually within 4 to 6 hours after coronary angiography.
Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by one physician who is blinded to the actual antithrombotic treatment given. Radial artery is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at baseline and after reevaluation on a second occasion, within 30 days after the index procedure. Initially patent arteries will not be reexamined and are thought to remain permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined as those extending beyond the forearm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Older than 18 years old
- •Scheduled for 5 or 6 Fr diagnostic coronary angiography
- •The interventional cardiologist is willing to proceed with radial access
- •Written informed consent
排除标准
- •Before randomization
- •chronic hemodialysis
- •oral anticoagulation
- •hemodynamic instability
- •severe dermo-myoskeletal forearm deformities
- •history of CABG and bilateral use of either the internal mammary or radial artery
- •history of CABG and ipsilateral use of both the internal mammary and radial artery
- •admission for elective PCI After randomization
- •crossover to another arterial access site is required
- •ad hoc PCI
研究组 & 干预措施
Standard dose of Heparin
50IU/Kg heparin intravenously
干预措施: Standard dose of Unfractionated heparin (Drug)
High dose of Heparin
100IU/Kg heparin intravenously
干预措施: High dose of Unfractionated Heparin (Drug)
结局指标
主要结局
Radial artery occlusion
时间窗: 30 days
Radial artery occlusion as assessed by Doppler Ultrasound
次要结局
- Major bleeding(30 days)
- Large local hematomas of the forearm(30 days)
研究者
Dimitrios Alexopoulos
Professor of Cardiology
University of Patras
