Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation - Full Text View

Sponsors and Collaborators:	University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00621491

Purpose

The purpose of this study is to evaluated whether prophylactic treatment with six-month use of warfarin could prevent transvenous leads-associated thrombosis in high risk patients.

Condition	Intervention	Phase
Venous Thrombosis Postoperative Complications	Drug: Warfarin	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Clinical Trial for the Prevention of Thromboembolic Complications After Transvenous Cardiac Devices Implantation in High Risk Patients

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

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:	200
Study Start Date:	February 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	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

Detailed Description:

Pacemaker and defibrillator transvenous leads frequently cause venous lesions, such as stenosis, occlusion or thrombosis. Previous temporary transvenous leads ipsilateral to the permanent implantation and lower left ventricular ejection fraction (LVEF) were associated with an increased risk of obstructions. The effect of prophylactic strategies to prevent these lesions remains controversial. Thus, the aim of this prospective, clinical, randomized, controlled and blinded study is evaluate whether prophylactic treatment with six-month use of warfarin could prevent transvenous leads-associated thrombosis in high risk patients. After device implantation, patients are randomly assigned to placebo or warfarin. Periodical clinical and laboratorial evaluations are performed to anticoagulant management. Following the six-month period, all patient are submitted to a digital subtraction venography and the prophylactic treatment will be discontinued.

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 devices implantation
left ventricular ejection fraction lower than 40% and/or
previous temporary transvenous leads ipsilaterally to the definitive implantation

Exclusion Criteria:

previous thromboembolic event (upper extremity deep venous thrombosis, pulmonary thromboembolism)
coagulopathy / thrombophilia
atrial fibrillation
mandatory use of anticoagulants
bleeding / active gastro-duodenal ulcer
Coagulogram abnormalities (INR ≥ 1.5)
malignant neoplasia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621491

Contacts

Contact: Katia R Silva, Nurse	55-11-3069-5284	katia.regina@incor.usp.br
Contact: Roberto Costa, MD PhD	55-11-3082-2130	rcosta@incor.usp.br

Locations

Brazil, SP
Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo	Recruiting
Sao Paulo, SP, Brazil, 05403-900
Contact: Katia R Silva, Nurse 55-11-3069-5284 katia.regina@incor.usp.br
Contact: Roberto Costa, MD PhD 55-11-3082-2130 rcosta@incor.usp.br
Sub-Investigator: Katia R Silva, Nurse
Principal Investigator: Roberto Costa, MD PhD
Sub-Investigator: Martino Martinelli Filho, MD PhD
Sub-Investigator: Roberto A Rached, MD PhD
Sub-Investigator: Silvana D Nishioka, MD PhD
Sub-Investigator: Cyrillo Cavalheiro Filho, MD PhD
Sub-Investigator: José Guilherme MP Caldas, MD PhD
Sub-Investigator: Francisco C Carnevale, MD PhD

Sponsors and Collaborators

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Investigators

Study Chair:	Roberto Costa, MD PhD	University of Sao Paulo
Principal Investigator:	Katia R Silva, Nurse	University of Sao Paulo

More Information

No publications provided

Responsible Party:	Heart Institute (Incor) - Hospital das Clínicas da Faculdade de Medicina ( Roberto Costa/ MD PhD )
Study ID Numbers:	SDC 2273/03/067
Study First Received:	February 11, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00621491 History of Changes
Health Authority:	Brazil: University of Sao Paulo

Keywords provided by University of Sao Paulo:

Venous Thrombosis
Cardiac Pacing
Postoperative Complications
Anticoagulants
Clinical Trials

Study placed in the following topic categories:

Embolism and Thrombosis
Anticoagulants
Postoperative Complications
Embolism

Vascular Diseases
Venous Thrombosis
Warfarin
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Anticoagulants
Pathologic Processes
Postoperative Complications
Therapeutic Uses
Hematologic Agents

Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Warfarin
Pharmacologic Actions
Thrombosis

ClinicalTrials.gov processed this record on September 04, 2009