Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

October 25, 2012 updated by: Roberto Costa, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-900
        • Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of venous obstructions observed by digital subtraction venography
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of anticoagulant therapy, morbidity and overall mortality
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC 2273/03/067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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