NCT00818688

Brief Summary

We performed a national cross-sectional and prospective large epidemiological cohort study in patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long documented by compression ultrasonography. Follow-up was three months. All events were adjudicated by a central committee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
844

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

5 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

March 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
Last Updated

January 13, 2009

Status Verified

January 1, 2009

Enrollment Period

1.6 years

First QC Date

January 7, 2009

Last Update Submit

January 12, 2009

Conditions

Thrombophlebitis

Keywords

Superficial thrombophlebitis (ST)Deep-vein thrombosisSymptomatic pulmonary embolismSymptomatic Superficial Thrombophlebitis of the lower limbs

Outcome Measures

Primary Outcomes (1)

  • Incidence of confirmed venous thromboembolism at three months.

    3 months

Secondary Outcomes (1)

  • Overall mortality at three months

    3 months

Study Arms (2)

1

Patients eligible for enrolment were all consecutive patients aged 18 years or over, with a symptomatic ST of the lower limbs at least 5 cm long on compression ultrasonography. Patients who had undergone surgery under general or loco-regional anaesthesia in the previous 10 days, those in whom ST had occurred after sclerotherapy within the previous 30 days and those whose follow-up was not considered to be feasible were ineligible.

Procedure: compression ultrasonography at 3 months

2

Patients eligible for enrolment were all consecutive patients aged 18 years or over, with a symptomatic ST of the lower limbs at least 5 cm long on compression ultrasonography. Patients who had undergone surgery under general or loco-regional anaesthesia in the previous 10 days, those in whom ST had occurred after sclerotherapy within the previous 30 days and those whose follow-up was not considered to be feasible were ineligible.

Interventions

compression ultrasonography at 3 monthsPROCEDURE

A three-month follow-up prospective study was performed in the subgroup of patients with symptomatic ST but without deep-vein thrombosis on compression ultrasonography or documented symptomatic pulmonary embolism at inclusion, a group defined as patients with 'isolated ST'.

1

Eligibility Criteria

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

Patients with symptomatic ST of the lower limbs.

You may qualify if:

  • all consecutive patients aged 18 years or over, with a symptomatic ST of the lower limbs at least 5 cm long on compression ultrasonography.

You may not qualify if:

  • patients who had undergone surgery under general or loco-regional anaesthesia in the previous 10 days, those in whom ST had occurred after sclerotherapy within the previous 30 days and those whose follow-up was not considered to be feasible were ineligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

LEANDRI

Annonay, 07100, France

Location

CHANUT

Aubenas, 07000, France

Location

GILLET

Bourgoin Jailleu, 38000, France

Location

Barrelier

Caen, 34000, France

Location

Guenneguez

Dieppe, France

Location

Related Publications (2)

  • Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

    PMID: 22429908DERIVED

  • Decousus H, Quere I, Presles E, Becker F, Barrellier MT, Chanut M, Gillet JL, Guenneguez H, Leandri C, Mismetti P, Pichot O, Leizorovicz A; POST (Prospective Observational Superficial Thrombophlebitis) Study Group. Superficial venous thrombosis and venous thromboembolism: a large, prospective epidemiologic study. Ann Intern Med. 2010 Feb 16;152(4):218-24. doi: 10.7326/0003-4819-152-4-201002160-00006.

    PMID: 20157136DERIVED

MeSH Terms

Conditions

ThrombophlebitisVenous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPhlebitisPeripheral Vascular DiseasesVasculitis

Study Officials

  • Hervé DECOUSUS, Pr

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

March 1, 2005

Primary Completion

October 1, 2006

Study Completion

January 1, 2007

Last Updated

January 13, 2009

Record last verified: 2009-01

Locations

FR(5)