Efficacy of a Single Dose Intravenous Heparin During Diagnostic Angiography in Reducing Sheath-clot Formation: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- The incidence of femoral arterial sheath thrombi and the efficacy of heparin bolus in preventing sheath thrombosis
研究概览
简要总结
The project tests the incidence of femoral arterial sheath thrombus formation during diagnostic coronary angiography and effect of intravenous (iv) heparin bolus administration in reducing this risk in comparison to placebo.
详细描述
PURPOSE:
The purpose of this study was to evaluate the incidence of blood clots in femoral arterial sheaths during coronary angiographic procedures and the effect of heparin administration on thrombus formation.
BACKGROUND:
A heparinized saline flushes are used during diagnostic coronary angiography to prevent thrombus formation within the lumen of the sheath. However, the use of prophylactic intravenous heparin following the femoral arterial sheath insertion is controversial. The aim of this study was to evaluate the effectiveness of 2000 units heparin intravenous bolus versus saline placebo on thrombus formation within arterial sheath during the diagnostic coronary angiography.
Methods A randomized controlled trial to examine the efficacy of intravenous heparin bolus compared with placebo in prevention of femoral arterial sheath thrombus formation in patients undergoing diagnostic coronary angiography.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included all adult patients undergoing cardiac catheterization
排除标准
- •Contraindication to heparin
- •Platelet count <100,000/mm3
- •Patient with bleeding diathesis or hypercoagulable state.
- •Use of chronic anticoagulation with INR > 1.4
- •Patient refusal or inability to follow the protocol
研究组 & 干预措施
active arm: heparin
干预措施: Heparin (Drug)
结局指标
主要结局
The incidence of femoral arterial sheath thrombi and the efficacy of heparin bolus in preventing sheath thrombosis
次要结局
未报告次要终点