Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-06-05
2027-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Association between thrombosis burden and occurrence of PTS
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
F-CRIN INNOVTE Research Network
UNKNOWN
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
OTHER
Responsible Party
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Principal Investigators
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Antoine ELIAS
Role: STUDY_DIRECTOR
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
Locations
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Centre Hospitalier de Carcassonne
Carcassonne, Aude, France
Hôpital d'Aubagne
Aubagne, Bouches-du-Rhône, France
Hôpital Saint Joseph
Marseille, Bouches-du-Rhône, France
Hôpital La Timone, AP-HM
Marseille, Bouches-du-Rhône, France
Cabinet libéral
Martigues, Bouches-du-Rhône, France
Cabinet libéral
Ajaccio, Corse-du-sud, France
Cabinet libéral
Ajaccio, Corse-du-sud, France
CHU de Dijon
Dijon, Côte d'Or, France
CHU de Besançon
Besançon, Doubs, France
Centre Hospitalier Universitaire de Brest
Brest, Finistère, France
Clinique Rive Gauche
Toulouse, Haut-Garonne, France
Centre de Santé Polyvalent de UGESSAP
Montoir-de-Bretagne, Loire-Atlantique, France
CHU Saint Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Hospices Civils de Lyon, Hôpital Edouard Herriot
Lyon, Rhône, France
Centre Hospitalier Universitaire Amiens Picardie
Amiens, Somme, France
Centre Hospitalier de Fréjus/Saint-Raphaël
Fréjus, Var, France
Polyclinique Les Fleurs
Ollioules, Var, France
Centre cardio-vasculaire Esterel
Saint-Raphaël, Var, France
Cabinet libéral
Sanary-sur-Mer, Var, France
Cabinet libéral
Six-Fours-les-Plages, Var, France
Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
Toulon, Var, France
Centre Hospitalier d'Avignon
Avignon, Vaucluse, France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Hôpital Saint Joseph
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A02652-43
Identifier Type: OTHER
Identifier Source: secondary_id
2022-CHITS-003
Identifier Type: -
Identifier Source: org_study_id
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