NCT01501175

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
848

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

7 active sites

Status
completed

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

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

December 27, 2011

Last Update Submit

February 12, 2013

Conditions

Keywords

superficial vein thrombosisSaint Etienne region

Outcome Measures

Primary Outcomes (1)

  • symptomatic SVT

    new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician

    1 year

Secondary Outcomes (2)

  • SVT risk factors

    1 year

  • SVT Clinical signs

    1 year

Study Arms (1)

patients with suspected SVT

patients with suspected SVT and inhabitants of the Saint Etienne region

Other: consultation with a vascular physician

Interventions

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.

patients with suspected SVT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with suspected SVT inhabitant of the Saint Etienne region

You may qualify if:

  • inhabitants of the Saint Etienne region
  • with suspected SVT
  • consulting general practitioners and or vascular physicians of the Saint Etienne region

You may not qualify if:

  • SVT not confirmed by compression ultrasonography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cabinet D'Angiologie

Firminy, 42700, France

Location

Ch Firminy

Firminy, 42700, France

Location

Cabinet D'Angiologie

Saint-Chamond, 42400, France

Location

Centre médical de Chavannes

Saint-Chamond, 42400, France

Location

Cabinet D'Angiologie

Saint-Etienne, 42000, France

Location

Chu Saint-Etienne

Saint-Etienne, 42000, France

Location

Clinique Mutualiste CHirurgicale de St-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Hervé DECOUSUS, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR
  • Paul FRAPPE, MD

    University of Saint-Etienne

    STUDY DIRECTOR
  • Bernard TARDY, MD PhD

    CHU de Saint Etienne

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2011

First Posted

December 29, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations