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NCT00232271 Clinical Trial

The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.

Deep Vein Thrombosis Clinical Trial

Official title:
The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00232271
Other study ID # 2004-157
Secondary ID
Status Terminated
Phase Phase 4
First received October 2, 2005
Last updated May 28, 2013
Start date August 2005
Est. completion date February 2011

Study information
Verified date October 2005
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 35
Est. completion date February 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Clexane

Locations
Country Name City State
Australia Royal Melbourne hospital Melbourne Victoria

Sponsors (3)
Lead Sponsor Collaborator
Melbourne Health National Heart Foundation, Australia, Sanofi

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of deep vein thrombosis 1 year No
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