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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02652-43 | Other Identifier | ID-RCB number |
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| Name | Class |
|---|---|
| Assistance Publique Hopitaux De Marseille | OTHER |
| F-CRIN INNOVTE Research Network | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Association between thrombosis burden and occurrence of PTS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Thrombosis burden | Thrombosis burden is assessed using the Venous Volumetric Index (VVI) as well as prognostic factors at baseline. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of moderate to severe PTS adjusted to other prognostic factors at baseline | PTS is assessed at 6 months by the Villalta scale. | 6 months |
| Thrombosis burden adjusted to other prognostic factors at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months and 6 months |
| General health related quality of life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali CESANA | Contact | 0483772060 | magali.cesana@ch-toulon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine ELIAS | Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de Vichy | Recruiting | Vichy | Allier | 03200 | France |
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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 | 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 | 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 | up to 6 months |
| Presence of moderate to severe PTS at baseline and at follow-up visits | 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 | The thrombus burden is assessed by the VVI index. | Baseline, 1 week, 1 month, 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 | D-dimers, plasminogen activator inhibitor 1 (PAI-1) | up to 3 months |
| Fibrinolytic and pro-coagulant activities of microvesicles/microparticles | up to 3 months |
| Centre Hospitalier de Carcassonne | Recruiting | Carcassonne | Aude | 11010 | France |
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| Hôpital d'Aubagne | Not yet recruiting | Aubagne | Bouches-du-Rhône | 13400 | France |
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| Hôpital Saint Joseph | Recruiting | Marseille | Bouches-du-Rhône | 13008 | France |
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| Hôpital La Timone, AP-HM | Recruiting | Marseille | Bouches-du-Rhône | 13385 | France |
|
| Cabinet libéral | Terminated | Martigues | Bouches-du-Rhône | 13500 | France |
| Cabinet libéral | Recruiting | Ajaccio | Corse-du-sud | 20090 | France |
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| Cabinet libéral | Recruiting | Ajaccio | Corse-du-sud | 20090 | France |
|
| CHU de Dijon | Recruiting | Dijon | Côte d'Or | 21000 | France |
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| CHU de Besançon | Recruiting | Besançon | Doubs | 25030 | France |
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| Centre Hospitalier Universitaire de Brest | Recruiting | Brest | Finistère | 29069 | France |
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| Clinique Rive Gauche | Recruiting | Toulouse | Haut-Garonne | 31076 | France |
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| CHU de Toulouse | Recruiting | Toulouse | Haute-Garonne | 31400 | France |
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| Centre de Santé Polyvalent de UGESSAP | Terminated | Montoir-de-Bretagne | Loire-Atlantique | 44550 | France |
| CHU Saint Etienne | Recruiting | Saint-Priest-en-Jarez | Pays de la Loire Region | 42270 | France |
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| Hospices Civils de Lyon, Hôpital Edouard Herriot | Recruiting | Lyon | Rhône | 69003 | France |
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| Centre Hospitalier Universitaire Amiens Picardie | Recruiting | Amiens | Somme | 830054 | France |
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| Centre Hospitalier de Fréjus/Saint-Raphaël | Terminated | Fréjus | Var | 83600 | France |
| Polyclinique Les Fleurs | Recruiting | Ollioules | Var | 83190 | France |
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| Centre cardio-vasculaire Esterel | Withdrawn | Saint-Raphaël | Var | 83700 | France |
| Cabinet libéral | Recruiting | Sanary-sur-Mer | Var | 83110 | France |
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| Cabinet libéral | Recruiting | Six-Fours-les-Plages | Var | 83140 | France |
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| Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer | Recruiting | Toulon | Var | 830054 | France |
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| Centre Hospitalier d'Avignon | Recruiting | Avignon | Vaucluse | 84000 | France |
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| Centre Hospitalier Universitaire de Nantes | Recruiting | Nantes | 44000 | France |
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| Hôpital Saint Joseph | Recruiting | Paris | 75014 | France |
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| Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
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