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临床试验/NCT02570243
NCT02570243已完成4 期

High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion Forearm Artery Occlusion

University of Patras1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

50IU/Kg heparin intravenously

干预措施: Standard dose of Unfractionated heparin (Drug)

High dose of Heparin

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrios Alexopoulos

Professor of Cardiology

University of Patras

研究点 (1)

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