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临床试验/NCT04374799
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2020年10月5日
干预措施HeparinPlacebos
相关药物HeparinPlacebos

概览

阶段
3 期
干预措施
Heparin
疾病 / 适应症
Cardiac Disease
发起方
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
入组人数
1623
试验地点
2
主要终点
radial artery occlusion
状态
招募中
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2020年10月5日
结束日期
2026年12月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

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

heparin (25 IU/Kg -maximal dose 3,000 IU)

干预措施: Heparin

High dose heparin

heparin 50 IU/kg -maximal dose 5,000 IU

干预措施: Heparin

Placebo

Normal saline 0.9%.

干预措施: Placebos

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)

研究点 (2)

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