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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.
Scientific title
The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Secondary ID [1] 0 0
2004-157
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clexane

Active Comparator: clexane - patients received clexane

No Intervention: non clexane - no clexane given


Treatment: Drugs: Clexane
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of deep vein thrombosis
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- Patients undergoing EPS/RFA for the diagnosis and or treatment of SVT based on patient
history or ECG evidence.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Heart Foundation, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00232271
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Sparks, MBBS, PhD. FRACP
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00232271