ThrombosisNCT01086046
Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
A study testing Low molecular weight heparin in people with Thrombosis, run by Third Military Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- Low molecular weight heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Hypertension
- Coronary artery disease
- Diabetes
- Atrial fibrillation and oral contraceptive medication
- Aspro, clopidogrel and warfarin in 2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
Chongqing, Chongqing Municipality, 400037
Lan Huang, +86 023 68755601, huanglan260@yahoo.com.cn
Jun Qin
About this study
Official title: 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.
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.
- Conditions
- Thrombosis
- Being tested
- Low molecular weight heparin
- Keywords
- platelet, thrombozyme, ASD, Heparin, Enoxaparin
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparinDrug
Also called Enoxaparin
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.
| Study group | Role | What they receive |
|---|---|---|
| Heparin | Active comparator | Heparin injection 10 IU/kg/hr within 24h Receives: 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 Receives: Drug: Low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
Measured: within the first 90 days after closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Medical University
- Responsible party
- Principal investigator, Jun Qin, Third Military Medical University
- Investigators
- lan huang, Study director, Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086046
- Sponsor's protocol ID
- cstc2009ab5033
- Status last verified
- Jan 2012
- First submitted
- 8 Mar 2010
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure
- ClinicalTrials.gov ID
- NCT01086046
- Acronym / sponsor ID
- cstc2009ab5033
- Conditions
- Thrombosis
- Keywords
- platelet, thrombozyme, ASD, Heparin, Enoxaparin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Chongqing Medical University
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin | Active comparator | Drug: Low molecular weight heparinHeparin injection 10 IU/kg/hr within 24h |
| Low molecular weight heparin | Experimental | Drug: Low molecular weight heparinLow 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 |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Hypertension
- Coronary artery disease
- Diabetes
- Atrial fibrillation and oral contraceptive medication
- Aspro, clopidogrel and warfarin in 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low molecular weight heparinAlso: EnoxaparinLow 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 | Heparin, Low molecular weight heparin |
Primary outcome
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure
Time frame: within the first 90 days after closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lan huang study director
Cardiovascular Department, Xinqiao Hospital, the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low molecular weight heparin in people with Thrombosis, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Qin (+86 023 68755601, qinjunqjqj@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Multicentre, Randomized Controlled Study of Blood Clotting After Percutaneous Atrial Septal Defect closure (time frame: within the first 90 days after closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.