POST (Prospective Observational Superfial Thrombophlebitis)

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00818688
First received: January 7, 2009
Last updated: January 12, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Thrombophlebitis
Procedure: compression ultrasonography at 3 months

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Incidence of confirmed venous thromboembolism at three months. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall mortality at three months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 844
Study Start Date: March 2005
Study Completion Date: January 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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'.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with symptomatic ST of the lower limbs.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818688

Locations
France
LEANDRI
Annonay, France, 07100
CHANUT
Aubenas, France, 07000
GILLET
Bourgoin Jailleu, France, 38000
Barrelier
Caen, France, 34000
Guenneguez
Dieppe, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Hervé DECOUSUS, Pr CHU de SAINT-ETIENNE
  More Information

No publications provided by Centre Hospitalier Universitaire de Saint Etienne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr DECOUSUS Hervé, CHU de SAINT-ETIENNE
ClinicalTrials.gov Identifier: NCT00818688     History of Changes
Other Study ID Numbers: 0401080
Study First Received: January 7, 2009
Last Updated: January 12, 2009
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Superficial thrombophlebitis (ST)
Deep-vein thrombosis
Symptomatic pulmonary embolism
Symptomatic Superficial Thrombophlebitis of the lower limbs

Additional relevant MeSH terms:
Thrombophlebitis
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on October 16, 2014