Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: Low molecular weight heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Hypertension Coronary artery disease Diabetes Atrial fibrillation and oral contraceptive medication Aspro, clopidogrel and warfarin in 2 weeks.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heparin<br>Heparin injection 10 IU/kg/hr within 24h | Drug: Low molecular weight heparin<br>* 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.<br>* Other names: Enoxaparin;|
| Experimental: Low molecular weight heparin<br>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 | Drug: Low molecular weight heparin<br>* 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.<br>* Other names: Enoxaparin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure |  | within the first 90 days after closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet, thrombozyme, ASD, Heparin, Enoxaparin