Prospective Epidemiological Study of Upper Limb Venous Thrombosis (Epi-TVMS)

September 20, 2023 updated by: Nantes University Hospital

Prospective Epidemiological Study Evaluating the Prevalence of Upper Limb Venous Thrombosis in a Population of Patients Hospitalized in a University Hospital

Venous thrombosis of the upper limb is one of the manifestations of venous thromboembolic disease.

The epidemiology and management of upper limb venous thrombosis is much less well documented than that of lower limb venous thrombosis.

The investigators wished to provide epidemiological data concerning upper limb venous thrombosis in the hospital setting.

The researchers would like to know the prevalence of this pathology among patients hospitalized in a university hospital center. In order to obtain this prevalence, the investigators wish to carry out a monocentric cross-sectional descriptive study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Venous thrombosis of the upper limb is one of the manifestations of venous thromboembolic disease.

The epidemiology and management of upper limb venous thrombosis is much less well documented than that of lower limb venous thrombosis.

The investigators wished to provide epidemiological data concerning upper limb venous thrombosis in the hospital setting.

The researchers would like to know the prevalence of this pathology among patients hospitalized in a university hospital center. In order to obtain this prevalence, the investigators wish to carry out a monocentric cross-sectional descriptive study.

The main objective of the study is to define the prevalence of upper limb venous thrombosis in patients hospitalized at Nantes University Hospital.

The secondary objectives are to describe the epidemiology according to the patient's hospitalization sector or the endovenous medical devices used. Another secondary objective is to describe the clinical signs associated with thromboses and their characteristics.

The investigators wish to include major patients hospitalized at the Nantes University Hospital in different sectors (medical, surgical, intensive care units). After collecting the patient's non-opposition, reseachers will carry out a venous duplex ultrasonography of the upper limbs.

Data concerning the hospitalization unit, the patient's comorbidities, the presence of venous tracts or other endo-venous devices, clinical signs and duplex ultrasonography data will be collected using a standardized collection grid.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Nantes university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All major patient hospitalized in a department of the Nantes University Hospital and accepting participation in this research

Description

Inclusion Criteria :

  • Patient (major, pregnant woman) hospitalized in a department of the Nantes University Hospital and accepting participation in this research

Exclusion Criteria :

  • Opposition to the completion of the review, minors, adults under guardianship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of upper limb venous thrombosis
Time Frame: through study completion, an average of 1 year
Number of upper limb venous thrombosis diagnosed in duplex ultrasonography compared to the number of patients examined.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiology and description of upper limb venous thrombosis
Time Frame: through study completion, an average of 1 year
Epidemiology of upper limb venous thrombosis according to the patient's hospitalization sector, the patient's history or the medical devices used (pacemaker, peripheral or central venous line, ...). Description of the clinical signs associated with upper limb venous thrombosis. These clinical signs will be correlated with the echodoppler characteristics of the upper limb venous thrombosis.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2020

Primary Completion (Actual)

January 12, 2023

Study Completion (Actual)

January 12, 2023

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC20_0121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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