Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJanuary 19, 2012
January 1, 2012
3.4 years
March 8, 2010
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
within the first 90 days after closure
Study Arms (2)
Heparin
ACTIVE COMPARATORHeparin injection 10 IU/kg/hr within 24h
Low molecular weight heparin
EXPERIMENTALLow 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hypertension
- Coronary artery disease
- Diabetes
- Atrial fibrillation and oral contraceptive medication
- Aspro, clopidogrel and warfarin in 2 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Third Military Medical Universitylead
- Chongqing Medical Universitycollaborator
Study Sites (1)
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
Chongqing, Chongqing Municipality, 400037, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
lan huang
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 12, 2010
Study Start
January 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 19, 2012
Record last verified: 2012-01