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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 : January 3, 2018
Sponsor:
Collaborator:
University of Ribeirao Preto
Information provided by (Responsible Party):
Selma Regina de Oliveira Raymundo, Fundação Faculdade Regional de Medicina de São José do Rio Preto

Brief Summary:

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

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Incidence of risk factors for DVT [ Time Frame: Five Years ]
    1. Inheriting a blood-clotting disorder.
    2. Prolonged bed rest, such as during a long hospital stay, or paralysis.
    3. Injury or surgery.
    4. Pregnancy.
    5. Birth control pills (oral contraceptives) or hormone replacement therapy.
    6. Being overweight or obese.
    7. Smoking.
    8. Cancer.
    9. Heart failure.
    10. Inflammatory bowel disease.
    11. A personal or family history of deep vein thrombosis or pulmonary embolism.
    12. Age. Being older than 60 increases your risk of DVT.


Secondary Outcome Measures :
  1. Types of treatment performed in the real world [ Time Frame: Five Years ]

    Anticoagulation.

    Types of treatment performed in the real world

    Description:

    Anticoagulation.

    • 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with venous thrombosis in any site, male or female, regardless of age, with first episode or recurrent episodes and with or without pulmonar embolism.
Criteria

Inclusion Criteria:

  • patients with venous thrombosis in any site, male or female, regardless of age, with first episode or recurrent episodes and with or without pulmonary embolism.

Exclusion Criteria:

  • There are no exclusion criteria

Information from the National Library of Medicine

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


Contacts
Contact: Selma R Raymundo, MD; PhD 55 17 996016062 selma_ray@terra.com.br
Contact: Edwaldo E Joviliano, MD; PhD 55 16 36021000 ext 2406 eejovilliano@gmail.com

Locations
Brazil
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    jvascbr.ed@gmail.com   
Contact: Marcone L Sobreira, MD; PhD    55 14 38116269    mlsobreira@gmail.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         
Sponsors and Collaborators
Fundação Faculdade Regional de Medicina de São José do Rio Preto
University of Ribeirao Preto
Investigators
Principal Investigator: Selma R Raymundo, MD; PhD Fundação Faculdade Regional de Medicina de São Jose Do Rio Preto

Responsible Party: Selma Regina de Oliveira Raymundo, Principal Investigator, Fundação Faculdade Regional de Medicina de São José do Rio Preto
ClinicalTrials.gov Identifier: NCT03388775     History of Changes
Other Study ID Numbers: DVT 2017
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Selma Regina de Oliveira Raymundo, Fundação Faculdade Regional de Medicina de São José do Rio Preto:
deep vein thrombosis
assessment
risk factors

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases