Actively Recruiting
DVT Burden and the Risk of Post-thrombotic Syndrome
Led by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Updated on 2026-04-13
400
Participants Needed
27
Research Sites
155 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead Sponsor
A
Assistance Publique Hopitaux De Marseille
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DVT Burden and the Risk of Post-thrombotic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Symptomatic acute deep venous thrombosis of the lower limbs confirmed by ultrasound by venous incompressibility and direct thrombus imaging
- Patients with stable pulmonary embolism alongside symptomatic deep venous thrombosis can be included
- Affiliated or beneficiary of a social security scheme
You will not qualify if you...
- Pregnant women, women in labor, or breastfeeding mothers
- Hemodynamically unstable pulmonary embolism defined by low blood pressure or shock
- Asymptomatic venous thrombosis
- Symptomatic venous thrombosis affecting both lower limbs (except when symptomatic on only one side)
- History of venous thrombosis in either lower limb
- Fracture or orthopedic surgery of the lower limbs within the past 3 months
- Dependence due to age or chronic illness affecting ability to stand or walk independently
- Use of prophylactic or therapeutic anticoagulant treatment for more than 5 days
- Expected anticoagulant treatment duration less than 3 months
- High risk of bleeding as judged by the investigator
- Need for interruption of inferior vena cava or venous recanalization procedures
- Refusal or inability to provide written informed consent
- Life expectancy less than 6 months
- Legal protection status such as guardianship or curatorship
- Participation in another venous thromboembolism research that could interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
CH de Vichy
Vichy, Allier, France, 03200
Not Yet Recruiting
2
Centre Hospitalier de Carcassonne
Carcassonne, Aude, France, 11010
Actively Recruiting
3
Hôpital d'Aubagne
Aubagne, Bouches-du-Rhône, France, 13400
Not Yet Recruiting
4
Hôpital Saint Joseph
Marseille, Bouches-du-Rhône, France, 13008
Actively Recruiting
5
Hôpital La Timone, AP-HM
Marseille, Bouches-du-Rhône, France, 13385
Actively Recruiting
6
Cabinet libéral
Martigues, Bouches-du-Rhône, France, 13500
Terminated
7
Cabinet libéral
Ajaccio, Corse-du-sud, France, 20090
Actively Recruiting
8
Cabinet libéral
Ajaccio, Corse-du-sud, France, 20090
Actively Recruiting
9
CHU de Dijon
Dijon, Côte d'Or, France, 21000
Actively Recruiting
10
CHU de Besançon
Besançon, Doubs, France, 25030
Actively Recruiting
11
Centre Hospitalier Universitaire de Brest
Brest, Finistère, France, 29069
Actively Recruiting
12
Clinique Rive Gauche
Toulouse, Haut-Garonne, France, 31076
Actively Recruiting
13
CHU de Toulouse
Toulouse, Haute-Garonne, France, 31400
Not Yet Recruiting
14
Centre de Santé Polyvalent de UGESSAP
Montoir-de-Bretagne, Loire-Atlantique, France, 44550
Terminated
15
CHU Saint Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42270
Actively Recruiting
16
Hospices Civils de Lyon, Hôpital Edouard Herriot
Lyon, Rhône, France, 69003
Actively Recruiting
17
Centre Hospitalier Universitaire Amiens Picardie
Amiens, Somme, France, 830054
Actively Recruiting
18
Centre Hospitalier de Fréjus/Saint-Raphaël
Fréjus, Var, France, 83600
Terminated
19
Polyclinique Les Fleurs
Ollioules, Var, France, 83190
Actively Recruiting
20
Centre cardio-vasculaire Esterel
Saint-Raphaël, Var, France, 83700
Withdrawn
21
Cabinet libéral
Sanary-sur-Mer, Var, France, 83110
Actively Recruiting
22
Cabinet libéral
Six-Fours-les-Plages, Var, France, 83140
Actively Recruiting
23
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
Toulon, Var, France, 830054
Actively Recruiting
24
Centre Hospitalier d'Avignon
Avignon, Vaucluse, France, 84000
Actively Recruiting
25
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44000
Actively Recruiting
26
Hôpital Saint Joseph
Paris, France, 75014
Actively Recruiting
27
Hôpital Européen Georges Pompidou
Paris, France, 75015
Not Yet Recruiting
Research Team
M
Magali CESANA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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