Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Roberto Costa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00621491
First received: February 11, 2008
Last updated: October 25, 2012
Last verified: January 2008
  Purpose

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.


Condition Intervention
Cardiac Pacing
Complications
Venous Thrombosis
Drug: Warfarin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Incidence of venous obstructions observed by digital subtraction venography [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of anticoagulant therapy, morbidity and overall mortality [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 101
Study Start Date: February 2004
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Single daily dose of Placebo during six months
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
Other Name: oral anticoagulants

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00621491

Locations
Brazil
Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, SP, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Chair: Roberto Costa, MD PhD University of Sao Paulo
Principal Investigator: Katia R Silva, RN PhD University of Sao Paulo
  More Information

Publications:
Responsible Party: Roberto Costa, MD PhD, Associate Professor of Cardiovascular Surgery, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00621491     History of Changes
Other Study ID Numbers: SDC 2273/03/067
Study First Received: February 11, 2008
Last Updated: October 25, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
cardiac pacing
pacing complication
venous thrombosis
warfarin
anticoagulation
randomized trial

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Anticoagulants
Warfarin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014