- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00232271
The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane on the development of leg clots following electrophysiology studies (EPS) and or radiofrequency ablation (RFA).
People who suffer heart palpitations will sometimes need hospital admission to undergo an electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat their condition.
Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies require the puncture of the leg veins . Previous experience has shown that following the puncture of leg veins there is a small risk of developing a blood clot in the leg.
It is not known whether giving blood thinners (anticoagulants) after the procedure will decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the legs
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3050
- Royal Melbourne Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing EPS/RFA for the diagnosis and or treatment of SVT based on patient history or ECG evidence.
Exclusion Criteria:
- Patients with a past history of DVT or PE.
- Patients with a history of clotting disorders
- Patients with active malignancies
- Patients requiring full heparinisation during and after the procedure.
- Chronic atrial flutter and atrial fibrillation ablation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: clexane
patients received clexane
|
|
No Intervention: non clexane
no clexane given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of deep vein thrombosis
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul Sparks, MBBS, PhD. FRACP, Melbourne Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-157
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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