The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Information source: Melbourne Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Deep Vein Thrombosis
Intervention: Clexane (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Melbourne Health Official(s) and/or principal investigator(s): Paul Sparks, MBBS, PhD. FRACP, Principal Investigator, Affiliation: Melbourne Health
Summary
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
Clinical Details
Official title: The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of deep vein thrombosis
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Royal Melbourne hospital, Melbourne, Victoria 3050, Australia
Additional Information
Starting date: August 2005
Last updated: May 28, 2013
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