An interventional study of Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome in Postthrombotic Syndrome, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Recruiting at 27 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Not applicable, Interventional, and Prevention
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.
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:
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.
73 studies on the registry are indexed under Postthrombotic Syndrome; 21 are open to participants now.
This study's planned enrollment of 400 is above the median of 95 across 46 interventional studies indexed under Postthrombotic Syndrome.
Browse Postthrombotic Syndrome studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Presence of moderate to severe Post-thrombotic Syndrome (PTS)
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.
Time frame: 6 months
Thrombosis burden
Thrombosis burden is assessed using the Venous Volumetric Index (VVI) as well as prognostic factors at baseline.
Time frame: Baseline
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline
PTS is assessed at 6 months by the Villalta scale.
Time frame: 6 months
Thrombosis burden adjusted to other prognostic factors at baseline
Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
Time frame: Baseline
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up
PTS is assessed at 6 months by the Villalta scale. Other prognostic factors related to anticoagulant therapy and compression are assessed during follow-up.
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up
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.
Time frame: 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
Presence of moderate to severe PTS at baseline and at follow-up visits
PTS is assessed by the Villalta scale.
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months
Thrombosis burden at baseline and at follow-up visits
The thrombus burden is assessed by the VVI index.
Time frame: Baseline, 1 week, 1 month, 3 months and 6 months
Disease specific health related quality of life
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.
Time frame: 3 months and 6 months
General health related quality of life
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.
Time frame: 3 months and 6 months
Coagulation and fibrinolysis markers
D-dimers, plasminogen activator inhibitor 1 (PAI-1)
Time frame: up to 3 months
Fibrinolytic and pro-coagulant activities of microvesicles/microparticles
Time frame: up to 3 months
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer