Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

January 18, 2012 updated by: Jun Qin, Third Military Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • Recruiting
        • Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
        • Contact:
        • Principal Investigator:
          • Jun Qin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Enoxaparin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Collaborators

Chongqing Medical University

Investigators

  • Study Director: lan huang, Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cstc2009ab5033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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