Cohort for Monitoring Patients With Venous Thromboembolic Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

Venous thromboembolic disease is a common pathology in the general population (1.5/1000), the prognosis of which depends in particular on the risk of recurrence. This risk depends essentially on whether the thrombotic episode was provoked or not. Thus, patients who present a thromboembolic event without any contributing factor have a high risk of recurrence, which encourages clinicians to continue anticoagulant treatment for a long time. However, anticoagulant treatment is the leading cause of hospitalization for iatrogenic causes and the leading cause of iatrogenic mortality. The benefit-risk balance of treatment must be evaluated regularly, which requires a good knowledge of the risk factors for thrombotic recurrence and the risk factors for hemorrhage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Deep vein thrombosis confirmed by Doppler ultrasound or CT venography,

Pulmonary embolism confirmed by CT angiography, ventilation/perfusion scan, or confirmed DVT episode with respiratory signs consistent with PE.

Hospitalization in the Internal Medicine Department

Consultation by an Internal Medicine physician

Disqualifiers

None

Trial population

Patient having experienced at least one venous thromboembolic episode

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Patient having experienced at least one venous thromboembolic episode

Trial outcomes

Primary outcomes

1

Rate of recurrence in patients treated with venous thromboembolic disease (VTE)

Evaluation of the number of hospitalizations or consultations for a venous thrombotic recurrence

Time frame
12 years
2

Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE)

Evaluation of the number of hospitalizations or consultations for a hemorrhagic complication.

Time frame
12 years

Secondary outcomes

1

Long-term complication rates

Assessment of the occurrence of long-term complications

Time frame
At enrollment visit, 6 months, 1 years and each year during 12 years
2

Long-term complication rates

Assessment of mortality

Time frame
At enrollment visit, 6 months, 1 years and each year during 12 years

Other outcomes

Sponsors and contacts

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