Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06385353

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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