Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation

Phase 4

Completed

• Conditions: Previous Vka Treatment; Previous Proximal VTE

• Registration Number: NCT00860106
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
VTE event recurrence	0-2 years

Trial Locations

Locations (6)

University Hospital; 🇫🇷 Amiens, France

Cabinet Medical; 🇫🇷 Voiron, France

HOSPITAL; 🇫🇷 Chambery, France

Vascular Medecine Departement - University Hospital of Grenoble; 🇫🇷 Grenoble, France

Clinique Mutualiste les eaux claires; 🇫🇷 Grenoble, France

CMC Les Petites Roches; 🇫🇷 Saint Hilaire Du Touvet, France