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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Previous Proximal VTE; Previous Vka Treatment

Treatments: Other: ED, DDimers and phone follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT00860106

DCIC 04 22

Details and patient eligibility

About

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.

Full description

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

Enrollment: 222 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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222 participants in 1 patient group

Follow up

Other group

Description:

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.

Treatment:

Other: ED, DDimers and phone follow up