Real World Study of Deep Venous Thrombosis. Analysis of Prospective Cases in University Hospitals of São Paulo (DVT)
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|ClinicalTrials.gov Identifier: NCT03388775|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : February 15, 2019
Background: Deep venous thrombosis (DVT) is a common and important vascular disease due to its morbidity and mortality.
Its incidence remains high throughout the world and constitutes serious problems for national and international public health.
Several inherited and/or acquired risk factors may be responsible for thrombus formation. Few epidemiological data regarding real world panorama of this disease in South America and Brazil is available in the literature.
Objective: Evaluate demographic data, diagnostic methods and treatment of deep vein thrombosis in the real world in public university hospitals in Brazil.
Methods: Five-year prospective records of deep venous thrombosis have been collected by the RHEUNI group of five public schools in the State of São Paulo.
Demographic data of patients will be evaluated along with the main risk factors, clinical picture, diagnostic methods, use of different drugs to treat the disease and its complications. Digital platform has been used in data collection. Is a multicenter study and analysis will be performed using Microsoft Excel and Epi-Info.
Key words: deep vein thrombosis, assessment, risk factors, demographic data.
|Condition or disease||Intervention/treatment|
|Registry||Other: deep venous thrombosis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Real World Study of Deep Venous Thrombosis in Brazil. Analysis of Prospective Cases in University Hospitals in the State of São Paulo|
|Actual Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Patients with deep venous thrombosis
Five-year prospective records of deep venous thrombosis have been collected by the RHEUNI group of five public schools in the State of São Paulo.
Demographic data of patients will be evaluated along with the main risk factors, clinical picture, diagnostic methods, use of different drugs to treat the disease and its complications.
Other: deep venous thrombosis
Five-year prospective analysis of deep venous thrombosis performed by the RHEUNI group of five public schools in the State of São Paulo.
- Incidence of risk factors for DVT [ Time Frame: Five Years ]
- Inheriting a blood-clotting disorder.
- Prolonged bed rest, such as during a long hospital stay, or paralysis.
- Injury or surgery.
- Birth control pills (oral contraceptives) or hormone replacement therapy.
- Being overweight or obese.
- Heart failure.
- Inflammatory bowel disease.
- A personal or family history of deep vein thrombosis or pulmonary embolism.
- Age. Being older than 60 increases your risk of DVT.
- Types of treatment performed in the real world [ Time Frame: Five Years ]
Types of treatment performed in the real world
- Unfractionated heparin, which is given into a vein (intravenously) - This may be the preferred choice in certain circumstances, such as if the patient has severe kidney failure or unstable blood pressure.
- Direct oral anticoagulants - These are available in pill form; they include rivaroxaban (brand name: Xarelto) and apixaban (brand name: Eliquis).
The choice of anticoagulant depends upon multiple factors, including the preference of the patient and the healthcare provider, the patient's medical history and other conditions, and cost considerations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388775
|Contact: Selma R Raymundo, MD; PhD||55 17 firstname.lastname@example.org|
|Contact: Edwaldo E Joviliano, MD; PhD||55 16 36021000 ext email@example.com|
|Clinics Hospital of Faculty of Medicine of Paulista State University||Recruiting|
|Botucatu, São Paulo, Brazil, 18607621|
|Contact: Winston B Yoshida, MD; PhD 55 14 38116269 firstname.lastname@example.org|
|Contact: Marcone L Sobreira, MD; PhD 55 14 38116269 email@example.com|
|Sub-Investigator: Winston B Yoshida, MD; PhD|
|Sub-Investigator: Marcone L Sobreira, MD; PhD|
|Sub-Investigator: Regina Moura, MD; PhD|
|Sub-Investigator: Edwaldo E Jovilliano, MD; PhD|
|Sub-Investigator: Ana T Guillaumon, MD; PhD|
|Sub-Investigator: Marcelo J Almeida, MD; PhD|
|Sub-Investigator: Daniel G Miquelin|
|Sub-Investigator: Ludvig Hafner|
|Sub-Investigator: Martin A Geiger|
|Principal Investigator:||Selma R Raymundo, MD; PhD||Fundação Faculdade Regional de Medicina de São Jose Do Rio Preto|