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 Details — Status: Completed

Administrative data

• NCT number: NCT00621491
• Other study ID #: SDC 2273/03/067
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: October 25, 2012
• Start date: February 2004
• Est. completion date: July 2008

Study information

• Verified date: January 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices

• left ventricular ejection fraction =0.40 and/or

• previous transvenous temporary leads ipsilateral to the permanent device implant

Exclusion Criteria:

• history of venous thromboembolism

• atrial fibrillation

• coagulopathy or platelet disorder

• malignancy

• gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months

• abnormal prothrombin time (PT)or an international normalized ratio (INR) >40%, or treated with oral anticoagulants

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

• Cardiac Pacing
• Complications
• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Costa R, Da Silva KR, Rached R, Martinelli Filho M, Carnevale FC, Moreira LF, Stolf NA. Prevention of venous thrombosis by warfarin after permanent transvenous leads implantation in high-risk patients. Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S247- — View Citation

Silva KR, Costa R, Abi Rached R, Martinelli Filho M, Caldas JG, Carnevale FC, Moreira LF, Stolf NA. Warfarin prevents venous obstruction after cardiac devices implantation in high-risk patients: partial analysis. Rev Bras Cir Cardiovasc. 2008 Oct-Dec;23(4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of venous obstructions observed by digital subtraction venography		Six months	Yes
Secondary	Safety of anticoagulant therapy, morbidity and overall mortality		Six months	Yes