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Assessing the risk of post-thrombotic syndrome in patients with deep vein thrombosis

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 -

Not applicable Interventional Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · NCT06385353

This study is trying to find out which patients with a first-time blood clot in their leg are more likely to develop post-thrombotic syndrome so that better treatments can be offered.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer Academic / other
Locations27 sites (Vichy, Allier and 26 other locations)
Trial IDNCT06385353 on ClinicalTrials.gov

What this trial studies

This multicenter prospective cohort study aims to evaluate the burden of deep vein thrombosis (DVT) and other prognostic factors that may predict the occurrence and severity of post-thrombotic syndrome (PTS). Patients diagnosed with a first episode of DVT in the lower limbs will be recruited and monitored through follow-up visits at one week, one month, three months, and six months. During these visits, clinical assessments, venous ultrasound evaluations, and blood samples will be collected to analyze inflammation and coagulation factors. The study seeks to identify high-risk patients to improve treatment strategies and reduce the incidence of PTS.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years and older who have been diagnosed with acute deep venous thrombosis of the lower limbs.

Not a fit: Patients with conditions such as active cancer, bilateral venous thrombosis, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better prevention and management strategies for patients at risk of developing post-thrombotic syndrome.

How similar studies have performed: Other studies have explored prognostic markers for post-thrombotic syndrome, but this specific approach focusing on DVT burden is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Vichy, Allier and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Postthrombotic SyndromeVenous thrombosisThrombus burdenUltrasonographyThrombus resolutionPost-thrombotic syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.