What is this study trying to find out about post-thrombotic syndrome?

This study aims to find out if the amount of blood clot in the veins (DVT burden) can predict who will develop post-thrombotic syndrome (PTS) and how severe it will be. Researchers want to improve treatment decisions and patient care by better understanding this risk. The study is led by the Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer.

Who may be eligible for this post-thrombotic syndrome clinical trial?

Adults 18 years or older with a first episode of symptomatic deep vein thrombosis in the lower limbs may be eligible. Both men and women can participate. Important factors include not being pregnant, not having recent lower limb surgery or fractures, and not having been on anticoagulants for more than 5 days. Please review eligibility criteria for more details.

Is there any cost to participate in this post-thrombotic syndrome clinical trial?

Study-related care, including all assessments and procedures, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06385353

Baseline Ultrasound Venous Thrombosis Burden and the Risk of Post-thrombotic Syndrome in Patients With a First Acute Episode of Symptomatic Deep Vein Thrombosis of the Lower Limbs - The DVT-Burden Project

Led by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Updated on 2026-04-13

400

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying post-thrombotic syndrome PTS, a common long-term complication of deep vein thrombosis DVT that affects quality of life and treatment costs. The study aims to evaluate whether the volume of thrombosis DVT burden, measured by the Venous Volumetric Index VVI using ultrasound, can predict the risk and severity of PTS at six months. This could help improve prediction and management strategies for patients with DVT. This multicenter prospective study enrolls patients with a first acute episode of symptomatic DVT in the lower limbs. Participants undergo assessments including ultrasound scans to calculate the VVI score and clinical evaluations using the Villalta score for PTS symptoms. Blood samples for inflammation and coagulation markers are collected at several visits, and quality of life questionnaires are completed at three and six months. Follow-up visits occur at one week, one month, three months, and six months. Participants will be evaluated through symptom assessments, ultrasound imaging, blood tests, and questionnaires over six months. The primary outcome is the presence of moderate to severe PTS at six months. Researchers will monitor thrombosis burden and other prognostic factors at each visit to understand their relationship with PTS development. The study concludes after the six-month visit with no further follow-up planned.

CONDITIONS

Brief Title

DVT Burden and the Risk of Post-thrombotic Syndrome

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Patients with symptomatic acute deep venous thrombosis of the lower limbs confirmed by ultrasound
Patients with stable pulmonary embolism associated with symptomatic deep venous thrombosis can be included
Affiliates or beneficiaries of a social security scheme

You will not qualify if you...

Pregnant women, women in labor, or breastfeeding mothers
Hemodynamically unstable pulmonary embolism (low blood pressure, shock, or cardiac arrest)
Asymptomatic venous thrombosis
Symptomatic venous thrombosis affecting both lower limbs (unless symptoms are only on one side)
History of venous thrombosis in either lower limb
Fracture or orthopedic surgery of lower limbs in the past 3 months
Dependence causing inability to stand or walk alone or bedridden
Anticoagulant treatment for more than 5 days
Expected anticoagulant treatment duration less than 3 months
High bleeding risk as judged by the investigator
Indication for vena cava interruption or venous recanalization procedures
Refusal or inability to provide written informed consent
Life expectancy less than 6 months
Under legal protection (guardianship, curatorship, etc.)
Participation in other venous thromboembolism research that may interfere with this study

Research Team

Magali CESANA

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