DVT Burden and the Risk of Post-thrombotic Syndrome

Launched by CENTRE HOSPITALIER INTERCOMMUNAL DE TOULON LA SEYNE SUR MER · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a condition called post-thrombotic syndrome (PTS), which can develop after a deep vein thrombosis (DVT) and significantly affect a patient's quality of life. The goal of the study is to find out if measuring the severity of DVT using a special scoring system called the Venous Volumetric Index (VVI) can help predict who is at risk of developing PTS and how severe it may be. By identifying patients at higher risk, doctors hope to improve treatment strategies and potentially prevent PTS from occurring.

To be eligible for the study, participants must be at least 18 years old and have been diagnosed with an acute DVT in their lower limbs, confirmed by an ultrasound. The study is looking for outpatients who meet certain health criteria and are willing to provide informed consent. Participants will undergo an ultrasound to measure their DVT burden and will be monitored for six months to see if they develop PTS. This research could lead to better management of DVT and improved outcomes for patients at risk of PTS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Patients with acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus
• • 3. Affiliates or beneficiaries of a social security scheme.
• Exclusion Criteria:
• • 1. Pregnant women, women in labour or breastfeeding mothers.
• • 2. Suspected or confirmed pulmonary embolism.
• • 3. Asymptomatic venous thrombosis.
• • 4. Bilateral venous thrombosis.
• • 5. History of ipsilateral or contralateral venous thrombosis of the lower limb.
• • 6. Trauma, 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. Active cancer defined as cancer for which treatment is ongoing, treatment has not been effective (recurrence or progression) or treatment is palliative.
• • 9. Time between onset of symptoms and diagnosis \> 14 days.
• • 10. Prophylactic or therapeutic anticoagulant treatment \> 72 hours.
• • 11. Expected duration of anticoagulant treatment \< 3 months (all patients must have a minimum treatment of 3 months).
• • 12. Known contraindication to anticoagulant treatment (chronic renal insufficiency defined by creatinine clearance \< 30 ml/min according to the Cockcroft-Gault formula; platelets \< 100,000/mm3; active bleeding or high risk of bleeding (gastric ulcer, recent haemorrhagic stroke, etc.); known liver disease (Child Pugh class B and class C)).
• • 13. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).
• • 14. Refusal or inability to give written informed consent to participate in the study.
• • 15. Life expectancy \< 6 months.
• • 16. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice.
• • 17. Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.