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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CH de Vichy
  Vichy, Allier, France Recruiting
• Centre Hospitalier de Carcassonne
  Carcassonne, Aude, France Recruiting
• Hôpital Saint Joseph
  Marseille, Bouches-du-Rhône, France Recruiting
• Hôpital La Timone, AP-HM
  Marseille, Bouches-du-Rhône, France Recruiting
• Cabinet libéral
  Ajaccio, Corse-du-sud, France Recruiting
• Cabinet libéral
  Ajaccio, Corse-du-sud, France Recruiting

Study contacts

• Study coordinator: Magali CESANA
• Email: magali.cesana@ch-toulon.fr
• Phone: 0483772060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.