Superficial Vein ThrombosisSTEPHNCT01501175
Incidence of Superficial Vein Thrombosis
An observational study of Superficial Vein Thrombosis, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.
Trial summary
To date, the investigators still do not know the annual incidence of Superficial Vein Thrombosis in the legs, although the investigators do know that this pathology is frequent and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is of 1 to 2 cases per year per 1,000 inhabitants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Vein Thrombosis
- What is being tested?
- consultation with a vascular physician
- How many people
- 848 participants
- Where
- 7 sitesFrance
- Study dates
- Nov 2011to Jan 2013
- 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: patients with suspected SVT inhabitant of the Saint Etienne region
Who may be able to join
- inhabitants of the Saint Etienne region
- with suspected SVT
- consulting general practitioners and or vascular physicians of the Saint Etienne region
Who cannot join
- SVT not confirmed by compression ultrasonography
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Cabinet D'Angiologie
Firminy, 42700
Ch Firminy
Firminy, 42700
Cabinet D'Angiologie
Saint-Chamond, 42400
Centre médical de Chavannes
Saint-Chamond, 42400
Cabinet D'Angiologie
Saint-Etienne, 42000
Chu Saint-Etienne
Saint-Etienne, 42000
Clinique Mutualiste CHirurgicale de St-Etienne
Saint-Etienne, 42000
About this study
Official title: Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs
To date, the investigators still do not know the annual incidence of Superficial Vein Thrombosis in the legs, although the investigators do know that this pathology is frequent and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so it is important to re-evaluate this rate on an unselected population from general practice.
Read the detailed description
The method is a prospective observational study involving all the general practitioners and vascular physicians of the Saint Etienne region, i.e. 276 general practitioners, 27 vascular physicians and 341,822 inhabitants. Any new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician would be listed over one year. The confirmed SVTs, directly seen by the vascular physicians would also be listed. The incidence would be calculated by relating the total number of SVTs observed to the number of inhabitants of the Saint Etienne region. Information on whether concomitant DVT exists or not at the time of the compression ultrasonography would also be collected.
- Conditions
- Superficial Vein Thrombosis
- Being tested
- consultation with a vascular physician
- Keywords
- superficial vein thrombosis, Saint Etienne region
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consultation with a vascular physicianOther
As in usual practice, patient with suspected SVT will consult a vascular physician to diagnose SVT and eventually DVP/PE associated. Vascular physician will collect risk factors of SVT.
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected SVT | patients with suspected SVT and inhabitants of the Saint Etienne region Receives: Other: consultation with a vascular physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic SVT
new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician
Measured: 1 year
Secondary outcomes (2)
SVT risk factors
SVT risk factors will be collected during consultation with vascular physician. They are: varicose veins, history of thromboembolism, autoimmune disease,cancer, immobilization, recent surgery
Measured: 1 year
SVT Clinical signs
SVT clinical signs will be collected during consultation with general practitioner and or vascular physician. They are: palpable cords, pain, erythematous area and surrounding edema.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Hervé DECOUSUS, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint EtiennePaul FRAPPE, MD, Study director, University of Saint-EtienneBernard TARDY, MD PhD, Study director, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501175
- Sponsor's protocol ID
- 1108036
- Other IDs
- 11.385
- Acronym
- STEPH
- Status last verified
- Feb 2013
- First submitted
- 27 Dec 2011
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs
- ClinicalTrials.gov ID
- NCT01501175
- Acronym / sponsor ID
- STEPH / 1108036
- Conditions
- Superficial Vein Thrombosis
- Keywords
- superficial vein thrombosis, Saint Etienne region
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Dec 2011 (estimated)
- 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.
To date, the investigators still do not know the annual incidence of Superficial Vein Thrombosis in the legs, although the investigators do know that this pathology is frequent and the investigators can assume its incidence is greater than Deep Vein Thrombosis which is of 1 to 2 cases per year per 1,000 inhabitants. Furthermore, the high percentage of SVT with concomitant DVT and Pulmonary Embolism only concerns patients seen in vascular medicine, so it is important to re-evaluate this rate on an unselected population from general practice.
Detailed description
The method is a prospective observational study involving all the general practitioners and vascular physicians of the Saint Etienne region, i.e. 276 general practitioners, 27 vascular physicians and 341,822 inhabitants. Any new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician would be listed over one year. The confirmed SVTs, directly seen by the vascular physicians would also be listed. The incidence would be calculated by relating the total number of SVTs observed to the number of inhabitants of the Saint Etienne region. Information on whether concomitant DVT exists or not at the time of the compression ultrasonography would also be collected.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with suspected SVT | – | Other: consultation with a vascular physicianpatients with suspected SVT and inhabitants of the Saint Etienne region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected SVT inhabitant of the Saint Etienne region
Key inclusion criteria (3 listed)
- inhabitants of the Saint Etienne region
- with suspected SVT
- consulting general practitioners and or vascular physicians of the Saint Etienne region
Key exclusion criteria (1 listed)
- SVT not confirmed by compression ultrasonography
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 |
|---|---|---|
| consultation with a vascular physicianAs in usual practice, patient with suspected SVT will consult a vascular physician to diagnose SVT and eventually DVP/PE associated. Vascular physician will collect risk factors of SVT. | Other | patients with suspected SVT |
Primary outcome
symptomatic SVT
Time frame: 1 year
new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician
2 secondary outcomes
SVT risk factors
Time frame: 1 year
SVT Clinical signs
Time frame: 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 13 Feb 2013.
Related trials for Superficial Vein Thrombosis
Not yet recruitingObservational study
Superficial Vein Thrombosis Testing in the Emergency Department
Superficial Vein Thrombosis, D-dimer
Not yet recruitingPhase 2
Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years.
Venous Malformation, Low Flow, Venous Malformations
Recruiting
Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences
Catheter Associated Infection
RecruitingPhase 4
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)
Venous Thromboembolism, Varicose Veins
RecruitingObservational study
Prospective Evaluation of the Treatment of Cancer Associated Superficial Venous
Superficial Vein Thrombosis, Cancer
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.
Hervé DECOUSUS, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Paul FRAPPE, MD study director
University of Saint-Etienne
Bernard TARDY, MD PhD study director
CHU de Saint Etienne
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Vein Thrombosis, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites 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 3 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 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
symptomatic SVT (time frame: 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 13 Feb 2013.