Cohort for Monitoring Patients With Venous Thromboembolic Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Several tools have been established and validated to help clinicians assess patients' bleeding risk, notably using the HAS BLED, haemorrage, and more recently the VTE BLED score. This latest score, published very recently, is the only one to have been validated in patients treated with direct oral anticoagulants. At the same time, we have recurrence risk scores such as HERDOO2, which allow us to identify patients at low risk of recurrence.
In order to improve the management of patients with venous thromboembolic disease, multidisciplinary thrombosis RCPs have been established since 2015, bringing together hemostasis specialists, internists, oncologists, and private vascular physicians to assist clinicians in managing complex cases. • Dedicated post-emergency consultations twice a week to streamline outpatient care for less serious patients This study aims to evaluate the effectiveness of these tools: score and RCP in the management of patients with venous thromboembolic disease.
Primary outcome measures
- Rate of recurrence in patients treated with venous thromboembolic disease (VTE) [Time frame: 12 years]
- Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE) [Time frame: 12 years]
Secondary outcome measures (2)
- Long-term complication rates [Time frame: At enrollment visit, 6 months, 1 years and each year during 12 years]
- Long-term complication rates [Time frame: At enrollment visit, 6 months, 1 years and each year during 12 years]
Eligibility criteria
Inclusion criteria
- Any patient over 18 years of age who has experienced at least one venous thromboembolic episode:
- 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
- File presented at the thrombosis multidisciplinary meeting
Exclusion criteria
Thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- University Hospital of Rouen — Rouen
Identifiers
NCT: NCT07016542 · 2018/352/OB · ID RCB : 2018-A02844-51