Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01086046

Enrollment

450

Registered

2010-03-12

Start date

2009-01-31

Completion date

2012-06-30

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis

Keywords

platelet, thrombozyme, ASD, Heparin, Enoxaparin

Brief summary

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

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.

Interventions

DRUGLow 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure	within the first 90 days after closure

Countries

China

Contacts

Primary ContactJun Qin

qinjunqjqj@yahoo.com.cn+86 023 68755601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026