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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00232271
Registration number
NCT00232271
Ethics application status
Date submitted
2/10/2005
Date registered
4/10/2005
Date last updated
30/05/2013
Titles & IDs
Public title
The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
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Scientific title
The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
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Secondary ID [1]
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2004-157
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Clexane
Active Comparator: clexane - patients received clexane
No Intervention: non clexane - no clexane given
Treatment: Drugs: Clexane
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of deep vein thrombosis
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Assessment method [1]
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Timepoint [1]
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1 year
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Eligibility
Key inclusion criteria
- Patients undergoing EPS/RFA for the diagnosis and or treatment of SVT based on patient
history or ECG evidence.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2011
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne hospital - Melbourne
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Recruitment postcode(s) [1]
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3050 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melbourne Health
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Sanofi
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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National Heart Foundation, Australia
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00232271
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Sparks, MBBS, PhD. FRACP
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Address
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Melbourne Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00232271
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