Back to resultsThe Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Primary Purpose
Deep Vein Thrombosis
Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Clexane
Sponsored by
About this trial
This is an interventional prevention trial for Deep Vein Thrombosis
Eligibility 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
Sites / Locations
- Royal Melbourne hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
clexane
non clexane
Arm Description
patients received clexane
no clexane given
Outcomes
Primary Outcome Measures
Incidence of deep vein thrombosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00232271
First Posted
October 2, 2005
Last Updated
May 28, 2013
Sponsor
Melbourne Health
Collaborators
Sanofi, National Heart Foundation, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00232271
Brief Title
The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Official Title
The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
August 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health
Collaborators
Sanofi, National Heart Foundation, Australia
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clexane
Arm Type
Active Comparator
Arm Description
patients received clexane
Arm Title
non clexane
Arm Type
No Intervention
Arm Description
no clexane given
Intervention Type
Drug
Intervention Name(s)
Clexane
Primary Outcome Measure Information:
Title
Incidence of deep vein thrombosis
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sparks, MBBS, PhD. FRACP
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Melbourne hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
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