Clinical trial NCT00818688: POST (Prospective Observational Superfial Thrombophlebitis)
Official title: Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombophlebitis
Keywords: Superficial thrombophlebitis (ST)
Deep-vein thrombosis
Symptomatic pulmonary embolism
Symptomatic Superficial Thrombophlebitis of the lower limbs
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2009-01-08
Enrollment: 844
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic ST of the lower limbs.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of confirmed venous thromboembolism at three months.
timeFrame: 3 months
Secondary outcomes:
measure: Overall mortality at three months
timeFrame: 3 months
Other outcomes:
Locations:
city: Annonay
country: France
facility: LEANDRI
city: Aubenas
country: France
facility: CHANUT
city: Bourgoin Jailleu
country: France
facility: GILLET
city: Caen
country: France
facility: Barrelier
city: Dieppe
country: France
facility: Guenneguez
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Hervé DECOUSUS, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.