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Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

Venous Thrombosis Clinical Trial

Official title:
Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients

Clinical Trial Summary

The aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.

Clinical Trial Description

Venous lesions following cardiac devices implantation are a common complication of transvenous access that may cause disease manifestations and difficulties during reoperations. These lesions tend to develop early, and their incidence decreases gradually within 6 months after device implantation. Ventricular dysfunction and previous transvenous temporary leads ipsilateral to the permanent implant are risk factors identified in a previous study performed at our institution and other risk factors have been reported recently.The usefulness of prophylactic therapeutic strategies to prevent these complications, however,remains unknown. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. After device implantation, patients were randomly assigned to receive either placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. Following the six-month period, every patient was submitted to a digital subtraction venography. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00621491
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase N/A
Start date February 2004
Completion date July 2008
View Details
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