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DVT Burden and the Risk of Post-thrombotic Syndrome
Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Summary
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.
Official title: 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 -
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-06-05
Completion Date
2027-06
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
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 (27)
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
Cabinet libéral
Sanary-sur-Mer, Var, France
Cabinet libéral
Six-Fours-les-Plages, Var, France
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
Toulon, Var, France
Centre Hospitalier d'Avignon
Avignon, Vaucluse, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Hôpital Saint Joseph
Paris, France
Hôpital Européen Georges Pompidou
Paris, France