Study of Blood Clotting After Transcatheter Atrial Septal... | NCT01086046

Studies
Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

NCT01086046

Sponsor

Third Military Medical University

Status

Unknown status

Last Update Posted

Jan 19, 2012Estimated

Enrollment

450Estimated

Phase

Not Applicable

Conditions

Thrombosis

Interventions

Low molecular weight heparin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Mar 8, 2010

First Submission Date that Met QC Criteria

Mar 11, 2010

First Posted Date

Mar 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Qin, A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure, Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Third Military Medical UniversityOTHER

Collaborators

Name	Class
Chongqing Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heparin	Active Comparator	Heparin injection 10 IU/kg/hr within 24h	Drug: Low molecular weight heparin
Low molecular weight heparin	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
Low molecular weight heparin	Drug	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 Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Qin	Contact	+86 023 68755601		qinjunqjqj@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
lan huang	Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University	Recruiting	Chongqing	Chongqing Municipality	400037	China

Condition Browse Module

MeSH Terms

ID	Term
D013927	Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006495	Heparin, Low-Molecular-Weight
D017984	Enoxaparin

Ancestor Terms

ID	Term
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided