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RECRUITINGINTERVENTIONAL

DVT Burden and the Risk of Post-thrombotic Syndrome

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 -

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS. The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT. This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 willing to sign a consent form to participate in the study. 13. Life expectancy \< 6 months. 14. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

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

Post-thrombotic syndrome will be assessed by the Villalta score until 6 months of follow-up. Data collected from colour doppler ultrasound will be used to calculate the Venous Volumetric Index to quantify deep vein thrombosis burden until 6 months of follow-up.

Locations (20)

CH de Vichy
Vichy, Allier, France
Centre Hospitalier de Carcassonne
Carcassonne, Aude, France
Hôpital d'Aubagne
Aubagne, Bouches-du-Rhône, France
Hôpital Saint Joseph
Marseille, Bouches-du-Rhône, France
Hôpital La Timone, AP-HM
Marseille, Bouches-du-Rhône, France
Cabinet libéral
Martigues, Bouches-du-Rhône, France
Cabinet libéral
Ajaccio, Corse-du-sud, France
Cabinet libéral
Ajaccio, Corse-du-sud, France
CHU de Dijon
Dijon, Côte d'Or, France
CHU de Besançon
Besançon, Doubs, France
Centre Hospitalier Universitaire de Brest
Brest, Finistère, France
Clinique Rive Gauche
Toulouse, Haut-Garonne, France
CHU de Toulouse
Toulouse, Haute-Garonne, France
Centre de Santé Polyvalent de UGESSAP
Montoir-de-Bretagne, Loire-Atlantique, France
CHU Saint Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Hospices Civils de Lyon, Hôpital Edouard Herriot
Lyon, Rhône, France
Centre Hospitalier Universitaire Amiens Picardie
Amiens, Somme, France
Centre Hospitalier de Fréjus/Saint-Raphaël
Fréjus, Var, France
Polyclinique Les Fleurs
Ollioules, Var, France
Centre cardio-vasculaire Esterel
Saint-Raphaël, Var, France