Prospective Epidemiological Study of Upper Limb Venous Thrombosis

Venous Thrombosis Clinical Trial

— Epi-TVMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339894
• Other study ID #: RC20_0121
• Status: Completed
• Start date: August 4, 2020
• Est. completion date: January 12, 2023

Study information

• Verified date: September 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Duplex ultrasonography (data collection by extra-corporeal non-invasive sensors)
Search for venous thrombosis and description of thrombosis

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of upper limb venous thrombosis	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	Epidemiology and description of upper limb venous thrombosis	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