Clinical trial NCT00860106: Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation
Official title: Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Previous Vka Treatment
Previous Proximal VTE
Keywords: VTE
VKA treatment
VKA treatment cessation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation.

The patients are included in the study from the anticoagulant treatment cessation. An ED score and a blood sample are performed at this time and one month later. Then, the patients are followed up by phone for 2 years.

Detailed description: DDimer levels are centralized in University Hospital of Grenoble at the end of the study

Eligibility criteria: Inclusion Criteria:

* \> 18 and \<80 years old
* First or second treated proximal VTE event (+/- Pulmonary embolism)
* Signed informed consent

Exclusion Criteria:

* Active cancer or currently treated
* Previous VTE\>2
* Long term anticoagulant treatment for VTE diseases
* Long term anticoagulant treatment for other diseases
* Pregnancy, parturient or breast feeding
* Person deprived of freedom by judicial or administrative decision
* Consent unsigned

Primary outcomes:
measure: VTE event recurrence
timeFrame: 0-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital
city: Annecy
country: France
facility: Cabinet Medical
city: Annecy
country: France
facility: HOSPITAL
city: Bourgoin Jallieu
country: France
facility: Cabinet Medical
city: Chalon Sur Saone
country: France
facility: Cabinet Medical
city: Chambery
country: France
facility: HOSPITAL
city: Crolles
country: France
facility: Cabinet Medical
city: Fontaine
country: France
facility: Cabinet Medical
city: Grenoble
country: France
facility: Vascular Medecine Departement - University Hospital of Grenoble
city: Grenoble
country: France
facility: Cabinet Medical
city: Grenoble
country: France
facility: Clinique Mutualiste les eaux claires
city: Meylan
country: France
facility: Cabinet Medical
city: Pontcharra
country: France
facility: Cabinet Medical
city: Saint Egreve
country: France
facility: Cabinet Medical
city: Saint Hilaire Du Touvet
country: France
facility: CMC Les Petites Roches
city: Voiron
country: France
facility: Cabinet Medical
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles PERNOD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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