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

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborators:
Sanofi
National Heart Foundation, Australia
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00232271
First received: October 2, 2005
Last updated: May 28, 2013
Last verified: October 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Deep Vein Thrombosis
 Drug: Clexane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Incidence of deep vein thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: August 2005
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: clexane
patients received clexane
 Drug: Clexane
No Intervention: non clexane
no clexane given

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232271

Locations
Australia, Victoria
Royal Melbourne hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Sanofi
National Heart Foundation, Australia
Investigators
Principal Investigator: Paul Sparks, MBBS, PhD. FRACP Melbourne Health
  More Information

No publications provided

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00232271     History of Changes
Other Study ID Numbers: 2004-157
Study First Received: October 2, 2005
Last Updated: May 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013