Venous ThrombosisEpi-TVMSNCT04339894
Prospective Epidemiological Study of Upper Limb Venous Thrombosis
An observational study of Venous Thrombosis, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Duplex ultrasonography (data collection by extra-corporeal non-invasive sensors)
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2020to 12 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All major patient hospitalized in a department of the Nantes University Hospital and accepting participation in this research
Who may be able to join
- Patient (major, pregnant woman) hospitalized in a department of the Nantes University Hospital and accepting participation in this research
Who cannot join
- Opposition to the completion of the review, minors, adults under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Thrombosis
- Being tested
- Duplex ultrasonography (data collection by extra-corporeal non-invasive sensors)
- Keywords
- Upper limb, Venous thrombosis, Prevalence, Epidemiology
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasonography (data collection by extra-corporeal non-invasive sensors)Other
Search for venous thrombosis and description of thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of upper limb venous thrombosis
Number of upper limb venous thrombosis diagnosed in duplex ultrasonography compared to the number of patients examined.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start4 Aug 2020
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339894
- Sponsor's protocol ID
- RC20_0121
- Acronym
- Epi-TVMS
- Status last verified
- Sep 2023
- First submitted
- 7 Apr 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Epidemiological Study Evaluating the Prevalence of Upper Limb Venous Thrombosis in a Population of Patients Hospitalized in a University Hospital
- ClinicalTrials.gov ID
- NCT04339894
- Acronym / sponsor ID
- Epi-TVMS / RC20_0121
- Conditions
- Venous Thrombosis
- Keywords
- Upper limb, Venous thrombosis, Prevalence, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All major patient hospitalized in a department of the Nantes University Hospital and accepting participation in this research
Key inclusion criteria (1 listed)
- Patient (major, pregnant woman) hospitalized in a department of the Nantes University Hospital and accepting participation in this research
Key exclusion criteria (1 listed)
- Opposition to the completion of the review, minors, adults under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duplex ultrasonography (data collection by extra-corporeal non-invasive sensors)Search for venous thrombosis and description of thrombosis | Other | – |
Primary outcome
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.
1 secondary outcome
Epidemiology and description of upper limb venous thrombosis
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of upper limb venous thrombosis (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.