Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

NCT ID: NCT00621491

Last Updated: 2012-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2008-07-31

Brief 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

Keywords

cardiac pacing; pacing complication; venous thrombosis; warfarin; anticoagulation; randomized trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

1

Single daily dose of Placebo during six months

Group Type: PLACEBO_COMPARATOR

Warfarin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

oral anticoagulants

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Roberto Costa

MD PhD, Associate Professor of Cardiovascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Costa, MD PhD

Role: STUDY_CHAIR

University of Sao Paulo

Katia R Silva, RN PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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:S247-51. doi: 10.1111/j.1540-8159.2008.02295.x.

Reference Type: RESULT

PMID: 19250106 (View on PubMed)

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):542-9. doi: 10.1590/s0102-76382008000400015. English, Portuguese.

Reference Type: RESULT

PMID: 19229428 (View on PubMed)

Other Identifiers

SDC 2273/03/067

Identifier Type: -

Identifier Source: org_study_id