protocolSection identificationModule nctId: NCT06385353, orgStudyIdInfo id: 2022-CHITS-003, secondaryIdInfos id: 2023-A02652-43, type: OTHER, domain: ID-RCB number, briefTitle: DVT Burden and the Risk of Post-thrombotic Syndrome, acronym: DVT-Burden, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, class: OTHER, collaborators name: Assistance Publique Hopitaux De Marseille, collaborators name: F-CRIN INNOVTE Research Network, descriptionModule briefSummary: 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., conditionsModule conditions: Postthrombotic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome, outcomesModule primaryOutcomes measure: Presence of moderate to severe Post-thrombotic Syndrome (PTS), primaryOutcomes measure: Thrombosis burden, secondaryOutcomes measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline, secondaryOutcomes measure: Thrombosis burden adjusted to other prognostic factors at baseline, secondaryOutcomes measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up, secondaryOutcomes measure: Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up, secondaryOutcomes measure: Time to complete resolution of the thrombus as a function of thrombosis burden at baseline, secondaryOutcomes measure: Presence of moderate to severe PTS at baseline and at follow-up visits, secondaryOutcomes measure: Thrombosis burden at baseline and at follow-up visits, otherOutcomes measure: Disease specific health related quality of life, otherOutcomes measure: General health related quality of life, otherOutcomes measure: Coagulation and fibrinolysis markers, otherOutcomes measure: Fibrinolytic and pro-coagulant activities of microvesicles/microparticles, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Carcassonne, city: Carcassonne, state: Aude, zip: 11010, country: France, contacts name: Géraldine PAOLI-CAZANAVE, role: CONTACT, email: geraldine.paoli-cazanave@ch-carcassonne.fr, geoPoint lat: 43.21667, lon: 2.35, locations facility: Cabinet libéral, city: Martigues, state: Bouches-du-Rhône, zip: 13500, country: France, contacts name: Damien DIAS, role: CONTACT, email: dam.dias@free.fr, geoPoint lat: 43.40735, lon: 5.05526, locations facility: Cabinet libéral, city: Ajaccio, state: Corse-du-sud, zip: 20090, country: France, contacts name: Jean-François SECONDI, role: CONTACT, email: dr.jf.secondi@gmail.com, geoPoint lat: 41.91888, lon: 8.73811, locations facility: Cabinet libéral, city: Ajaccio, state: Corse-du-sud, zip: 20090, country: France, contacts name: Céline DE MARI, role: CONTACT, email: dr.celine.demari@gmail.com, geoPoint lat: 41.91888, lon: 8.73811, locations facility: Centre Hospitalier Universitaire de Brest, city: Brest, state: Finistère, zip: 29069, country: France, contacts name: Benjamin ESPINASSE, role: CONTACT, email: Benjamin.espinasse@chu-brest.fr, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Clinique Rive Gauche, city: Toulouse, state: Haut-Garonne, zip: 31076, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Hospices Civils de Lyon, Hôpital Edouard Herriot, city: Lyon, state: Rhône, zip: 69003, country: France, contacts name: Judith CATELLA, role: CONTACT, email: judith.catella@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Centre Hospitalier Universitaire Amiens Picardie, city: Amiens, state: Somme, zip: 830054, country: France, contacts name: Simon SOUDET, role: CONTACT, email: Soudet.simon@chu-amiens.fr, geoPoint lat: 49.9, lon: 2.3, locations facility: Centre Hospitalier de Fréjus/Saint-Raphaël, city: Fréjus, state: Var, zip: 83600, country: France, contacts name: Hatem BOUGHIDA, role: CONTACT, email: hatemboughida@yahoo.fr, geoPoint lat: 43.43286, lon: 6.73524, locations facility: Polyclinique Les Fleurs, city: Ollioules, state: Var, zip: 83190, country: France, contacts name: Anaïs CORNE, role: CONTACT, email: anaiscorne@gmail.com, geoPoint lat: 43.13517, lon: 5.848, locations facility: Centre cardio-vasculaire Esterel, city: Saint-Raphaël, state: Var, zip: 83700, country: France, geoPoint lat: 43.42332, lon: 6.7735, locations facility: Cabinet libéral, city: Sanary-sur-Mer, state: Var, zip: 83110, country: France, contacts name: Colin RICHARD, role: CONTACT, email: colin.richard29@gmail.com, geoPoint lat: 43.11783, lon: 5.80007, locations facility: Cabinet libéral, city: Six-Fours-les-Plages, state: Var, zip: 83140, country: France, contacts name: Sophia BENSEDRINE, role: CONTACT, email: sophia.ange@wanadoo.fr, geoPoint lat: 43.1, lon: 5.85, locations facility: Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer, city: Toulon, state: Var, zip: 830054, country: France, contacts name: Jean-Noël POGGI, role: CONTACT, email: jeannoel.poggi@ch-toulon.fr, geoPoint lat: 43.12442, lon: 5.92836, locations facility: Centre Hospitalier d'Avignon, city: Avignon, state: Vaucluse, zip: 84000, country: France, contacts name: Olivier GRAS, role: CONTACT, email: GRAS.Olivier@ch-avignon.fr, geoPoint lat: 43.94834, lon: 4.80892, hasResults: False