Incidence of Superficial Vein Thrombosis

Superficial Vein Thrombosis Clinical Trial

— STEPH  

Official title:

Evaluation of Annual Incidence of Superficial Vein Thrombosis in the Legs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501175
• Other study ID #: 1108036
• Secondary ID: 11.385
• Status: Completed
• Phase: N/A
• First received: December 27, 2011
• Last updated: February 12, 2013
• Start date: November 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• inhabitants of the Saint Etienne region

• with suspected SVT

• consulting general practitioners and or vascular physicians of the Saint Etienne region

Exclusion Criteria:

• SVT not confirmed by compression ultrasonography

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Superficial Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• consultation with a vascular physician
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.

Locations

Country	Name	City	State
France	Cabinet D'Angiologie	Firminy
France	Ch Firminy	Firminy
France	Cabinet D'Angiologie	Saint Chamond
France	Cabinet D'Angiologie	Saint Etienne
France	Centre médical de Chavannes	Saint-chamond
France	Cabinet D'Angiologie	Saint-etienne
France	Chu Saint-Etienne	Saint-etienne
France	Clinique Mutualiste CHirurgicale de St-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	1 year	No
Secondary	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.	1 year	No