Incidence of Superficial Vein Thrombosis (STEPH)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01501175
First received: December 27, 2011
Last updated: February 12, 2013
Last verified: February 2013

December 27, 2011
February 12, 2013
November 2011
November 2012   (final data collection date for primary outcome measure)
symptomatic SVT [ Time Frame: 1 year ] [ Designated as safety issue: No ]
new case of symptomatic SVT in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician
Same as current
Complete list of historical versions of study NCT01501175 on ClinicalTrials.gov Archive Site
  • SVT risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    SVT risk factors will be collected during consultation with vascular physician. They are: varicose veins, history of thromboembolism, autoimmune disease,cancer, immobilization, recent surgery
  • SVT Clinical signs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.
SVT risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
SVT risk factors will be collected during consultation wtih vascular physician. There are: varicose veins, history of thromboembolism, autoimmune disease,cancer, immobilization, recent surgery
Not Provided
Not Provided
 
Incidence of Superficial Vein Thrombosis
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

patients with suspected SVT inhabitant of the Saint Etienne region

Superficial Vein Thrombosis
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.
patients with suspected SVT
patients with suspected SVT and inhabitants of the Saint Etienne region
Intervention: Other: consultation with a vascular physician
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
848
January 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01501175
1108036, 11.385
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Hervé DECOUSUS, MD PhD CHU SAINT-ETIENNE
Study Director: Paul FRAPPE, MD University of Saint Etienne
Study Director: Bernard TARDY, MD PhD CHU de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP