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.
Age ≥ 18 years
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)
Affiliates or beneficiaries of a social security scheme.
Pregnant women, women in labour or breastfeeding mothers.
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.
Asymptomatic venous thrombosis.
Symptomatic venous thrombosis of both lower limbs (patients with bilateral deep venous thrombosis but symptomatic on one side only can be included).
Single group
Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome
Other interventionPost-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.
Thrombosis burden
Thrombosis burden is assessed using the Venous Volumetric Index (VVI) as well as prognostic factors at baseline.
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline
PTS is assessed at 6 months by the Villalta scale.
Thrombosis burden adjusted to other prognostic factors at baseline
Thrombosis burden is assessed using the VVI index as well as prognostic factors at 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.
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.
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.
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.
Coagulation and fibrinolysis markers
D-dimers, plasminogen activator inhibitor 1 (PAI-1)
Fibrinolytic and pro-coagulant activities of microvesicles/microparticles
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead sponsor
Assistance Publique Hopitaux De Marseille
Collaborator
F-CRIN INNOVTE Research Network
Collaborator
