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

Melbourne Health

Status and phase: Terminated; Phase 4

Conditions: Deep Vein Thrombosis

Treatments: Drug: Clexane

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00232271

2004-157

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

clexane

Active Comparator group

Description:

patients received clexane

Treatment:

Drug: Clexane

non clexane

No Intervention group

Description:

no clexane given