DVT Burden and the Risk of Post-thrombotic Syndrome

Last updated: January 27, 2025
Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Thrombosis

Claudication

Treatment

Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome

Clinical Study ID

NCT06385353
2022-CHITS-003
2023-A02652-43
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Patients with acute deep venous thrombosis of the lower limbs confirmed byultrasound on the criteria of venous incompressibility and direct image of thethrombus

  3. Affiliates or beneficiaries of a social security scheme.

Exclusion

Exclusion Criteria:

  1. Pregnant women, women in labour or breastfeeding mothers.

  2. Suspected or confirmed pulmonary embolism.

  3. Asymptomatic venous thrombosis.

  4. Bilateral venous thrombosis.

  5. History of ipsilateral or contralateral venous thrombosis of the lower limb.

  6. Trauma, fracture or orthopedic surgery of the lower limbs in the last 3 months.

  7. Dependance caused by age or secondary to a chronic affection, going from theinability to stand up or walk alone without help to bed or armchair rest over.

  8. Active cancer defined as cancer for which treatment is ongoing, treatment has notbeen effective (recurrence or progression) or treatment is palliative.

  9. Time between onset of symptoms and diagnosis > 14 days.

  10. Prophylactic or therapeutic anticoagulant treatment > 72 hours.

  11. Expected duration of anticoagulant treatment < 3 months (all patients must have aminimum treatment of 3 months).

  12. Known contraindication to anticoagulant treatment (chronic renal insufficiencydefined by creatinine clearance < 30 ml/min according to the Cockcroft-Gaultformula; platelets < 100,000/mm3; active bleeding or high risk of bleeding (gastriculcer, recent haemorrhagic stroke, etc.); known liver disease (Child Pugh class Band class C)).

  13. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).

  14. Refusal or inability to give written informed consent to participate in the study.

  15. Life expectancy < 6 months.

  16. Patients under legal protection (guardianship, curatorship, etc.) or safeguard ofjustice.

  17. Patients taking part in a research project for venous thromboembolism that caninterfere with the conduct of DVT-BURDEN research.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome
Phase:
Study Start date:
June 05, 2024
Estimated Completion Date:
June 30, 2027

Study Description

This is a multicenter prospective cohort study aiming at assessing baseline DVT-Burden and other prognostic factors for predicting the occurrence and the severity of PTS.

Patients diagnosed with a first episode of DVT of the lower limbs are recruited in offices and departments of vascular medicine. They will be informed of the study by their physician. If patients agree to take part and meet the eligibility criteria, they will be included consecutively in the study after signing an informed consent form.

The study will include follow-up visits at one week (D7±2, for patients participating in the biological research only), 1 month (D30±5), 3 months (D90±5) and 6 months (D180±5).

At each visit, the following examinations will be carried out:

  • Assessment of symptoms and clinical signs to evaluate the Villalta score.

  • Venous ultrasound evaluation of the lower limbs by colour Doppler ultrasound (CDUS). Data collected will be useful to calculate the VVI score planned at the study analysis phase.

At the D0, D7, D30 and D90 visits, blood samples will be taken for research purposes to assess factors of inflammation, coagulation and fibrinolysis.

At the D90 and D180 visits, the patient will also be asked to complete the VEINES-QOL and SF-36 quality of life questionnaires.

The patient's participation in the research will end at the end of the D180 visit.

Connect with a study center

  • Centre Hospitalier de Carcassonne

    Carcassonne, Aude 11010
    France

    Active - Recruiting

  • Hôpital d'Aubagne

    Aubagne, Bouches-du-Rhône 13400
    France

    Site Not Available

  • Hôpital La Timone, AP-HM

    Marseille, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Hôpital Saint Joseph

    Marseille, Bouches-du-Rhône 13008
    France

    Site Not Available

  • Cabinet libéral

    Martigues, Bouches-du-Rhône 13500
    France

    Terminated

  • Cabinet libéral

    Ajaccio, Corse-du-sud 20090
    France

    Active - Recruiting

  • CHU de Besançon

    Besançon, Doubs 25030
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Brest

    Brest, Finistère 29069
    France

    Site Not Available

  • Clinique Rive Gauche

    Toulouse, Haut-Garonne 31076
    France

    Active - Recruiting

  • CHU Saint Etienne

    Saint-Priest-en-Jarez, Loire 42270
    France

    Site Not Available

  • Centre de Santé Polyvalent de UGESSAP

    Montoir-de-Bretagne, Loire-Atlantique 44550
    France

    Site Not Available

  • Hospices Civils de Lyon, Hôpital Edouard Herriot

    Lyon, Rhône 69003
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Amiens Picardie

    Amiens, Somme 830054
    France

    Active - Recruiting

  • Centre Hospitalier de Fréjus/Saint-Raphaël

    Fréjus, Var 83600
    France

    Active - Recruiting

  • Polyclinique Les Fleurs

    Ollioules, Var 83190
    France

    Active - Recruiting

  • Centre cardio-vasculaire Esterel

    Saint-Raphaël, Var 83700
    France

    Site Not Available

  • Cabinet libéral

    Sanary-sur-Mer, Var 83110
    France

    Active - Recruiting

  • Cabinet libéral

    Six-Fours-les-Plages, Var 83140
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer

    Toulon, Var 830054
    France

    Active - Recruiting

  • Centre Hospitalier d'Avignon

    Avignon, Vaucluse 84000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • Hôpital Saint Joseph

    Paris, 75014
    France

    Site Not Available

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