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

NCT ID: NCT00232271

Last Updated: 2013-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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clexane

patients received clexane

Group Type ACTIVE_COMPARATOR

Clexane

Intervention Type DRUG

non clexane

no clexane given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clexane

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

National Heart Foundation, Australia

OTHER

Sponsor Role collaborator

Melbourne Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Sparks, MBBS, PhD. FRACP

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

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Royal Melbourne hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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2004-157

Identifier Type: -

Identifier Source: org_study_id

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