NCT00232271

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 30, 2013

Status Verified

October 1, 2005

Enrollment Period

5.4 years

First QC Date

October 2, 2005

Last Update Submit

May 28, 2013

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of deep vein thrombosis

    1 year

Study Arms (2)

clexane

ACTIVE COMPARATOR

patients received clexane

Drug: Clexane

non clexane

NO INTERVENTION

no clexane given

Interventions

ClexaneDRUG
clexane

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing EPS/RFA for the diagnosis and or treatment of SVT based on patient history or ECG evidence.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Melbourne hospital

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Paul Sparks, MBBS, PhD. FRACP

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2005

First Posted

October 4, 2005

Study Start

August 1, 2005

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

May 30, 2013

Record last verified: 2005-10

Locations

AU(1)