DVT Burden and the Risk of Post-thrombotic Syndrome (DVT-Burden)

April 10, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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 -

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nantes, France, 44000
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes
        • Contact:
      • Paris, France, 75015
      • Paris, France, 75014
        • Recruiting
        • Hopital Saint Joseph
        • Contact:
    • Allier
    • Aude
    • Bouches-du-Rhône
      • Aubagne, Bouches-du-Rhône, France, 13400
      • Marseille, Bouches-du-Rhône, France, 13008
        • Recruiting
        • Hopital Saint Joseph
        • Contact:
      • Marseille, Bouches-du-Rhône, France, 13385
      • Martigues, Bouches-du-Rhône, France, 13500
        • Terminated
        • Cabinet libéral
    • Corse-du-sud
    • Côte d'Or
    • Doubs
      • Besançon, Doubs, France, 25030
        • Recruiting
        • CHU de Besançon
        • Contact:
    • Finistère
    • Haut-Garonne
      • Toulouse, Haut-Garonne, France, 31076
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
    • Loire-Atlantique
      • Montoir-de-Bretagne, Loire-Atlantique, France, 44550
        • Terminated
        • Centre de Santé Polyvalent de UGESSAP
    • Pays de la Loire Region
      • Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42270
    • Rhône
      • Lyon, Rhône, France, 69003
    • Somme
      • Amiens, Somme, France, 830054
    • Var
      • Fréjus, Var, France, 83600
        • Terminated
        • Centre Hospitalier de Fréjus/Saint-Raphaël
      • Ollioules, Var, France, 83190
      • Saint-Raphaël, Var, France, 83700
        • Withdrawn
        • Centre cardio-vasculaire Esterel
      • Sanary-sur-Mer, Var, France, 83110
      • Six-Fours-les-Plages, Var, France, 83140
      • Toulon, Var, France, 830054
    • Vaucluse
      • Avignon, Vaucluse, France, 84000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients with symptomatic acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus (patients with stable pulmonary embolism associated with a symptomatic deep venous thrombosis can be included)
  3. Affiliates or beneficiaries of a social security scheme.

Exclusion Criteria:

  1. Pregnant women, women in labour or breastfeeding mothers.
  2. Pulmonary embolism haemodynamically unstable defined by systolic blood pressure < 90 mmHg or a drop in systolic blood pressure of at least 40 mmHg during at least 15 min, shock or cardiac arrest.
  3. Asymptomatic venous thrombosis.
  4. Symptomatic venous thrombosis of both lower limbs (patients with bilateral deep venous thrombosis but symptomatic on one side only can be included).
  5. History of ipsilateral or contralateral venous thrombosis of the lower limb.
  6. 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 the inability to stand up or walk alone without help to bed or armchair rest over.
  8. Prophylactic or therapeutic anticoagulant treatment > 5 days.
  9. Expected duration of anticoagulant treatment < 3 months (all patients must have a minimum treatment of 3 months).
  10. Patient estimated at high risk of bleeding according to investigator clinical judgment (renal, platelet, digestive, hepatic, neurological... origin) .
  11. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).
  12. Refusal or inability to give written informed consent to participate in the study.
  13. Life expectancy < 6 months.
  14. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice.
  15. Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Association between thrombosis burden and occurrence of PTS
Other: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome

Post-thrombotic syndrome will be assessed by the Villalta score until 6 months of follow-up.

Data collected from colour doppler ultrasound will be used to calculate the Venous Volumetric Index to quantify deep vein thrombosis burden until 6 months of follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of moderate to severe Post-thrombotic Syndrome (PTS)
Time Frame: 6 months

The primary outcome measure is the presence of moderate or severe PTS at 6 months as determined by a Villalta score ≥ 10 or the presence of an ulcer. The Villalta score considers items based on symptoms and clinical signs, including skin complications, each assessed on a scale from 0 to 3. The Villalta score is used to diagnose PTS and categorise its severity, according to international recommendations.

Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
6 months
Thrombosis burden
Time Frame: Baseline
Thrombosis burden is assessed using the Venous Volumetric Index (VVI) as well as prognostic factors at baseline.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline
Time Frame: 6 months
PTS is assessed at 6 months by the Villalta scale.
6 months
Thrombosis burden adjusted to other prognostic factors at baseline
Time Frame: Baseline
Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
Baseline
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up
Time Frame: Baseline, 1 week, 1 month, 3 months and 6 months
PTS is assessed at 6 months by the Villalta scale. Other prognostic factors related to anticoagulant therapy and compression are assessed during follow-up.
Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up
Time Frame: Baseline, 1 week, 1 month, 3 months and 6 months

Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.

Other prognostic factors related to anticoagulant therapy and compression are assessed during follow-up.
Baseline, 1 week, 1 month, 3 months and 6 months
Time to complete resolution of the thrombus as a function of thrombosis burden at baseline
Time Frame: up to 6 months
up to 6 months
Presence of moderate to severe PTS at baseline and at follow-up visits
Time Frame: Baseline, 1 week, 1 month, 3 months and 6 months
PTS is assessed by the Villalta scale.
Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden at baseline and at follow-up visits
Time Frame: Baseline, 1 week, 1 month, 3 months and 6 months
The thrombus burden is assessed by the VVI index.
Baseline, 1 week, 1 month, 3 months and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease specific health related quality of life
Time Frame: 3 months and 6 months
Disease specific health related quality of life will be assessed by the Venous Insufficiency Epidemiological and Economic Study quality of life and symptom (VEINES-QOL/Sym) questionnaires.
3 months and 6 months
General health related quality of life
Time Frame: 3 months and 6 months

General health related quality of life will be assessed by the 36-Item Short Form health questionnaire (SF-36).

A high score corresponds to better health/quality of life.
3 months and 6 months
Coagulation and fibrinolysis markers
Time Frame: up to 3 months
D-dimers, plasminogen activator inhibitor 1 (PAI-1)
up to 3 months
Fibrinolytic and pro-coagulant activities of microvesicles/microparticles
Time Frame: up to 3 months
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborators

Assistance Publique Hopitaux De Marseille
F-CRIN INNOVTE Research Network

Investigators

  • Study Director: Antoine ELIAS, Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-CHITS-003
  • 2023-A02652-43 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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