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Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

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ClinicalTrials.gov Identifier: NCT01086046
Recruitment Status : Unknown
Verified January 2012 by Jun Qin, Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : March 12, 2010
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
Chongqing Medical University
Information provided by (Responsible Party):
Jun Qin, Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: Low molecular weight heparin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Study Start Date : January 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Heparin
Heparin injection 10 IU/kg/hr within 24h
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.

Other Name: Enoxaparin

Experimental: 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

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.

Other Name: Enoxaparin




Primary Outcome Measures :
  1. A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure [ Time Frame: within the first 90 days after closure ]


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Ages Eligible for Study:   3 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086046


Contacts
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Contact: Jun Qin +86 023 68755601 qinjunqjqj@yahoo.com.cn

Locations
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China, Chongqing
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400037
Contact: Lan Huang    +86 023 68755601    huanglan260@yahoo.com.cn   
Principal Investigator: Jun Qin         
Sponsors and Collaborators
Third Military Medical University
Chongqing Medical University
Investigators
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Study Director: lan huang Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University

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Responsible Party: Jun Qin, A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01086046     History of Changes
Other Study ID Numbers: cstc2009ab5033
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012
Keywords provided by Jun Qin, Third Military Medical University:
platelet
thrombozyme
ASD
Heparin
Enoxaparin
Additional relevant MeSH terms:
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Thrombosis
Heart Septal Defects
Heart Septal Defects, Atrial
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action