Comparaison d'un Traitement systématique à l'héparine Versus sélectif Pour la prévention de l'Occlusion Radiale EASY-Héparine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Rates of patent hemostasis
研究概览
简要总结
Randomized study comparing the systematic use of heparin (standard of care) against an elective use of heparin to prevent radial artery occlusion after a percutaneous catheterization using a dual-artery compression system.
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
- None
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
- •Any patient referred for a diagnostic transradial catheterism
排除标准
- •Unable to understand study design or provide informed consent
- •Unable to receive antiplatelet therapy with aspirina and/or clopidogrel-prasugrel and/or ticagrelor and intravenous anticoagulant derived from heparine or bivalirudine
- •Local condition such as hematoma or pseudo-aneurims precluding radial or ulnar access.
- •Presence of plethysmographic waveform with simultaneous radial and ulnar occlusive compression (due to colaterals or interouseous artery) precluding the evaluation of patent hemostasis.
研究组 & 干预措施
Heparin
Standard of care with 70-100 IU/kg of heparin after a diagnostic only trans-radial catheterization and a dual-artery compression device for hemostasis.
No heparin
No heparin administered after diagnostic only trans-radial catheterization and a dual-artery compression device for hemostasis.
干预措施: No heparin (Other)
结局指标
主要结局
Rates of patent hemostasis
时间窗: within 24 hours after diagnostic angiography
Evaluation of patent hemostasis by pulse oximetry
Time to hemostasis
时间窗: within 24 hours post-procedure
Nursing time involvement
时间窗: within 24 hours post-procedure
Calculation of nursing time required for surveillance and care of hemostasis
Evaluation of complications
时间窗: within 30 days of procedure
Compilation of access site complications such as radial artery occlusion, bleeding, presence and grading of hematomas, etc.
次要结局
未报告次要终点
研究者
Olivier F. Bertrand
MD
Laval University