NCT03388775

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 12, 2025

Status Verified

December 1, 2023

Enrollment Period

12.4 years

First QC Date

October 31, 2017

Last Update Submit

March 10, 2025

Conditions

Keywords

deep vein thrombosisassessmentrisk factors

Outcome Measures

Primary Outcomes (1)

  • Incidence of risk factors for DVT

    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.

    Five Years

Secondary Outcomes (1)

  • Types of treatment performed in the real world

    Five Years

Study Arms (1)

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

Interventions

Five-year prospective analysis of deep venous thrombosis performed by the RHEUNI group of five public schools in the State of São Paulo.

Patients with deep venous thrombosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital of Faculty of Medicine of Paulista State University

Botucatu, São Paulo, 18607621, Brazil

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Selma R Raymundo, MD; PhD

    Fundação Faculdade Regional de Medicina de São Jose Do Rio Preto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Selma R Raymundo, MD; PhD

CONTACT

Edwaldo E Joviliano, MD; PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2017

First Posted

January 3, 2018

Study Start

July 1, 2013

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 12, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations