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DVT Burden and the Risk of Post-thrombotic Syndrome

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Intercommunal de Toulon La Sey…
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In plain words

What the trial is, and whether it could suit you

Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity. Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thro

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with symptomatic acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus (patients with stable pulmonary embolism associated with a symptomatic deep venous thrombosis can be included) 3. Affiliates or beneficiaries of a social security scheme. Exclusion Criteria: 1. Pregnant women, women in labour or breastfeeding mothers. 2. Pulmonary embolism haemodynamically unstable defined by systolic blood pressure \< 90 mmHg or a drop in systolic blood pressure of at least 40 mmHg during at least 15 min, shock or cardiac arrest. 3. Asymptomatic venous thrombosis. 4. Symptomatic venous thrombosis of both lower limbs (patients with bilateral deep venous thrombosis but symptomatic on one side only can be included). 5. History of ipsilateral or contralateral venous thrombosis of the lower limb. 6. Fracture or orthopedic surgery of the lower limbs in the last 3 months. 7. Dependance caused by age or secondary to a chronic affection, going from the inability to stand up or walk alone without help to bed or armchair rest over. 8. Prophylactic or therapeutic anticoagulant treatment \> 5 days. 9. Expected duration of anticoagulant treatment \< 3 months (all patients must have a minimum treatment of 3 months). 10. Patient estimated at high risk of bleeding according to investigator clinical judgment (renal, platelet, digestive, hepatic, neurological... origin) . 11. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery). 12. Refusal or inability to give written informed consent to participate in the study. 13. Life expectancy \< 6 months. 14. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice. 15. Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.
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What it tests

  • Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome
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Where

27 sites
CH de Vichy
Vichy, France
Centre Hospitalier de Carcassonne
Carcassonne, France
Hôpital d'Aubagne
Aubagne, France
Hôpital Saint Joseph
Marseille, France
Hôpital La Timone, AP-HM
Marseille, France
Cabinet libéral
Martigues, France
Cabinet libéral
Ajaccio, France
Cabinet libéral
Ajaccio, France

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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