Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation
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| First Received Date ICMJE | February 11, 2008 | ||||||||
| Last Updated Date | October 25, 2012 | ||||||||
| Start Date ICMJE | February 2004 | ||||||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of venous obstructions observed by digital subtraction venography [ Time Frame: Six months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00621491 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Safety of anticoagulant therapy, morbidity and overall mortality [ Time Frame: Six months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation | ||||||||
| Official Title ICMJE | Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Placebo Comparator: 1
Single daily dose of Placebo during six months
Intervention: Drug: Warfarin |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 101 | ||||||||
| Completion Date | July 2008 | ||||||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00621491 | ||||||||
| Other Study ID Numbers ICMJE | SDC 2273/03/067 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Roberto Costa, University of Sao Paulo | ||||||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||||||
| Verification Date | January 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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