POST (Prospective Observational Superfial Thrombophlebitis)

Completed

• Conditions: Thrombophlebitis
• Interventions: Procedure: compression ultrasonography at 3 months

• Registration Number: NCT00818688
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Between March 2005 and October 2006, 844 patients (median age \[range\]: 65 \[18-98\] years; 547 women) were included. At inclusion, confirmed deep-vein thrombosis and/or symptomatic pulmonary embolism was associated with ST in 24.9% (n=210) of patients. Among the 600 patients with isolated ST (i.e. without deep-vein thrombosis or pulmonary embolism at inclusion), 10.4% (n=56) developed venous thromboembolic complications at three months, including the following symptomatic events: pulmonary embolism (0.4%, n=2), deep-vein thrombosis (2.8%, n=15), extension of ST (3.1%, n=17) and recurrence of ST (1.9%, n=10). These complications occurred despite the use of various anticoagulant strategies in 90.5% (n=540) of patients; four independent risk factors increased the risk of these complications: male sex, cardiac or respiratory insufficiency, history of deep-vein thrombosis or pulmonary embolism and no history of varicose veins.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2006-10
• Study Completion: 2007-01
• Status Verified: 2009-01
• Study First Submitted: 2009-01-07
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Last Update Submitted: 2009-01-12
• Last Update Posted: 2009-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 844

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	compression ultrasonography at 3 months	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.

Primary Outcome Measures

Name	Time	Method
Incidence of confirmed venous thromboembolism at three months.	3 months

Secondary Outcome Measures

Name	Time	Method
Overall mortality at three months	3 months

Trial Locations

Locations (5)

LEANDRI; 🇫🇷 Annonay, France

CHANUT; 🇫🇷 Aubenas, France

GILLET; 🇫🇷 Bourgoin Jailleu, France

Barrelier; 🇫🇷 Caen, France

Guenneguez; 🇫🇷 Dieppe, France