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临床试验/NCT01086046
NCT01086046Unknown不适用

A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Third Military Medical University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Heparin injection 10 IU/kg/hr within 24h

干预措施: Low molecular weight heparin (Drug)

Low molecular weight heparin

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Qin

A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Third Military Medical University

研究点 (1)

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