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
• Interventions: Other: ED, DDimers and phone follow up

• 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

Arm && Interventions

Group	Intervention	Description
Follow up	ED, DDimers and phone follow up	ED score and DDimer level of patients who have stopped their VKA treatment (after the first or the second previous proximal VTE). Phone follow up for 2 years.

Primary Outcome Measures

Name	Time	Method
VTE event recurrence	0-2 years

Trial Locations

Locations (6)

Cabinet Medical; 🇫🇷 Voiron, France

HOSPITAL; 🇫🇷 Chambery, France

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

University Hospital; 🇫🇷 Amiens, France

Clinique Mutualiste les eaux claires; 🇫🇷 Grenoble, France

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