Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Primary Purpose
Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low molecular weight heparin
Sponsored by
About this trial
This is an interventional prevention trial for Thrombosis focused on measuring platelet, thrombozyme, ASD, Heparin, Enoxaparin
Eligibility 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.
Sites / Locations
- Cardiovascular Department, Xinqiao Hospital, the Third Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Heparin
Low molecular weight heparin
Arm Description
Heparin injection 10 IU/kg/hr within 24h
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
Outcomes
Primary Outcome Measures
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
Secondary Outcome Measures
Full Information
NCT ID
NCT01086046
First Posted
March 8, 2010
Last Updated
January 18, 2012
Sponsor
Third Military Medical University
Collaborators
Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01086046
Brief Title
Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Official Title
A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
Collaborators
Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
platelet, thrombozyme, ASD, Heparin, Enoxaparin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heparin
Arm Type
Active Comparator
Arm Description
Heparin injection 10 IU/kg/hr within 24h
Arm Title
Low molecular weight heparin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Other Intervention Name(s)
Enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
Time Frame
within the first 90 days after closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Qin
Phone
+86 023 68755601
Email
qinjunqjqj@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lan huang
Organizational Affiliation
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Huang
Phone
+86 023 68755601
Email
huanglan260@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Jun Qin
12. IPD Sharing Statement
Learn more about this trial
Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
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