Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Third Military Medical University

Status: Unknown

Conditions: Thrombosis

Treatments: Drug: Low molecular weight heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01086046

cstc2009ab5033

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 3 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Heparin

Active Comparator group

Description:

Heparin injection 10 IU/kg/hr within 24h

Treatment:

Drug: Low molecular weight heparin

Low molecular weight heparin

Experimental group

Description:

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

Treatment:

Drug: Low molecular weight heparin