A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
研究概览
简要总结
The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.
详细描述
Atrial septal defect (ASD) is a common clinical congenital heart disease. It is estimated that the congenital heart disease increase in children by about 15 million annual in China , of which ASD accounted for 10% to 15%. Secundum ASD is the most common clinical type of ASD, of which about 70% is suited to tanscatheter close.With the cardiac catheterization advancing and the devices developing in recent years ,the method has gradually replaced open-chest surgical repair to the person with Secundum ASD. At present, the most widely used device is Amplatzer occluder. With the wide ues of the occlur,there has gradually emerged occluder thrombosis after closure.there are much different methods to antiplatelet and anticoagulation,not only in China but also in the world.so we perfom the study to evaluating the blood clotting after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.
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
- 3 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age≥3 years
- •Diameter of defect≥5mm and increasing volume load of right heart
- •≤36 mm secondary left to right shunt
- •The distance between defective edge and coronaria venosus sinus, inferior caval vein, superior vena and pulmonary vein≥ 5 mm, between artrial-ventricular valve≥7 mm
- •The diameter of defect>Occluder
- •No other cardiac anomalies need surgery intervention
排除标准
- •Hypertension
- •Coronary artery disease
- •Atrial fibrillation and oral contraceptive medication
- •Aspro, clopidogrel and warfarin in 2 weeks.
研究组 & 干预措施
Heparin
Heparin injection 10 IU/kg/hr within 24h
干预措施: Low molecular weight heparin (Drug)
Low molecular weight heparin
Low molecular weight heparin sodium injection 1mg/kg 2 times in 24 hour
Low molecular weight heparin sodium injection 1mg/kg 2 times per day in 3 days
干预措施: Low molecular weight heparin (Drug)
结局指标
主要结局
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
时间窗: within the first 90 days after closure
次要结局
未报告次要终点
研究者
Jun Qin
A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Third Military Medical University
