NCT00621491

Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cardiac Pacing
• Complications
• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Warfarin	Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-09-01
• Completion: 2008-07-01
• First posted: 2008-02-22
• Last updated: 2012-10-26

Locations

1 site across 1 country: Brazil