Relationship Between Activated Clotting Time and Occlusion of Radial Artery When Used as Vascular Access for Percutaneous Endovascular Procedures.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,168
- 试验地点
- 1
- 主要终点
- incidence of radial occlusion
研究概览
简要总结
Observational cohort registry: prospective, multicenter independent evaluation of patients who undergo coronary angiography and/or PCI via radial artery. The purpose of this registry is to set the incidence of RAO according to ACT values, considered both as continuous and ordinal variable and its determinants. Coronary angiography and PCI will be performed according to usual practice.
详细描述
Trial objectives and purposes
Our objective was to evaluate:
i. relationship between activated clotting time (ACT), measured before sheath removal and incidence of radial artery occlusion (RAO), assessed by continuous Doppler and confirmed by echoDoppler before discharge from the hospital.
ii. the relationship between RAO and other clinical and procedural characteristics, to assess independent predictors of RAO.
Trial design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients > 18 years
- •Planned transradial endovascular procedure
- •Written informed consent signed by the patient as approved by the Ethics Committee
排除标准
- •Planned femoral access
- •Impossible bilateral radial puncture.
- •Anticipated impossible assess of radial patency (for example: patient transferred to other hospital immediately after the procedure)
- •use of bivalirudin as anticoagulant during PCI
- •use of low-molecular weight heparin (LMWH) within 12 hours from the PCI
- •Participation in another medical research study within 3 months of study enrollment
- •The patient has a co-morbidity that reduces life expectancy to < 1 month
- •Positive pregnancy assessment
研究组 & 干预措施
ACT < 150 sec
patients who received 5000 U of heparin (in coronary angiography) or according to weight (in PCI) and having ACT value before sheath removal below 150 sec
干预措施: heparin (Drug)
ACT between 150 and 249 sec
patients who received 5000 U of heparin (in coronary angiography) or according to weight (in PCI) and having ACT value before sheath removal between 150 and 249 sec
干预措施: heparin (Drug)
ACT >= 250 sec
patients who received 5000 U of heparin (in coronary angiography) or according to weight (in PCI) and having ACT value before sheath removal above 250 sec
干预措施: heparin (Drug)
结局指标
主要结局
incidence of radial occlusion
时间窗: 24 hours
次要结局
- incidence of pseudoaneurysm at site of vascular access(24 hours)
- incidence of procedural success(24 hours)
- incidence of symptoms related to vascular access(24 hours)
- MACCEs at 12 months(12 months)
- incidence of significant forearm hematoma(24 hours)