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 -

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Patients with acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus

• Affiliates or beneficiaries of a social security scheme.

Locations
Other Locations
France
Cabinet libéral
RECRUITING
Ajaccio
Cabinet libéral
RECRUITING
Ajaccio
Centre Hospitalier Universitaire Amiens Picardie
RECRUITING
Amiens
Hôpital d'Aubagne
NOT_YET_RECRUITING
Aubagne
Centre Hospitalier d'Avignon
RECRUITING
Avignon
CHU de Besançon
NOT_YET_RECRUITING
Besançon
Centre Hospitalier Universitaire de Brest
RECRUITING
Brest
Centre Hospitalier de Carcassonne
RECRUITING
Carcassonne
Centre Hospitalier de Fréjus/Saint-Raphaël
RECRUITING
Fréjus
Hospices Civils de Lyon, Hôpital Edouard Herriot
RECRUITING
Lyon
Hôpital La Timone, AP-HM
NOT_YET_RECRUITING
Marseille
Hôpital Saint Joseph
RECRUITING
Marseille
Cabinet libéral
TERMINATED
Martigues
Centre de Santé Polyvalent de UGESSAP
RECRUITING
Montoir-de-bretagne
Centre Hospitalier Universitaire de Nantes
RECRUITING
Nantes
Polyclinique Les Fleurs
RECRUITING
Ollioules
Hôpital Saint Joseph
NOT_YET_RECRUITING
Paris
CHU Saint Etienne
NOT_YET_RECRUITING
Saint-priest-en-jarez
Centre cardio-vasculaire Esterel
NOT_YET_RECRUITING
Saint-raphaël
Cabinet libéral
RECRUITING
Sanary-sur-mer
Cabinet libéral
RECRUITING
Six-fours-les-plages
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
RECRUITING
Toulon
Clinique Rive Gauche
RECRUITING
Toulouse
Contact Information
Primary
Magali CESANA
magali.cesana@ch-toulon.fr
0483772060
Time Frame
Start Date: 2024-06-05
Estimated Completion Date: 2027-06
Participants
Target number of participants: 400
Treatments
Experimental: Association between thrombosis burden and occurrence of PTS
Sponsors
Collaborators: Assistance Publique Hopitaux De Marseille, F-CRIN INNOVTE Research Network
Leads: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

This content was sourced from clinicaltrials.gov