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Status unknownNCT01086046Updated Jan 19, 2012

Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

An interventional study of Low molecular weight heparin in Thrombosis, sponsored by Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 3 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-19.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
3 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thrombosis

Keywords

  • platelet
  • thrombozyme
  • ASD
  • Heparin
  • Enoxaparin
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 239 are open to participants now.

This study's planned enrollment of 450 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 60 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Hypertension
  • Coronary artery disease
  • Diabetes
  • Atrial fibrillation and oral contraceptive medication
  • Aspro, clopidogrel and warfarin in 2 weeks.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants (estimated)

Study arms

  • Active comparator
    Heparin

    Heparin injection 10 IU/kg/hr within 24h

    Drug: Low molecular weight heparin

  • 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

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.

    Also known as: Enoxaparin

06

What researchers measure

Primary outcomes

  1. A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure

    Time frame: within the first 90 days after closure

07

Study locations

1 of 1 sites recruiting
  • Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
    Chongqing, Chongqing 400037, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01086046
Lead sponsor
Third Military Medical University
Collaborators
Chongqing Medical University
Responsible party
Jun Qin (A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure, Third Military Medical University) — Principal investigator
First posted
Mar 12, 2010
Start date
Jan 2009
Primary completion
Jun 2012 (estimated)
Completion
Jun 2012 (estimated)
Last update
Jan 19, 2012

Study contacts

Jun Qin
Contact
qinjunqjqj@yahoo.com.cn
+86 023 68755601
lan huang
study director · Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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