Clinical trial NCT06385353: DVT Burden and the Risk of Post-thrombotic Syndrome
Official title: 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 -
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postthrombotic Syndrome
Keywords: Venous thrombosis
Thrombus burden
Ultrasonography
Thrombus resolution
Post-thrombotic syndrome
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
name: F-CRIN INNOVTE Research Network
First posted: 2024-04-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus
3. Affiliates or beneficiaries of a social security scheme.

Exclusion Criteria:

1. Pregnant women, women in labour or breastfeeding mothers.
2. Suspected or confirmed pulmonary embolism.
3. Asymptomatic venous thrombosis.
4. Bilateral venous thrombosis.
5. History of ipsilateral or contralateral venous thrombosis of the lower limb.
6. Trauma, 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. Active cancer defined as cancer for which treatment is ongoing, treatment has not been effective (recurrence or progression) or treatment is palliative.
9. Time between onset of symptoms and diagnosis \> 14 days.
10. Prophylactic or therapeutic anticoagulant treatment \> 72 hours.
11. Expected duration of anticoagulant treatment \< 3 months (all patients must have a minimum treatment of 3 months).
12. Known contraindication to anticoagulant treatment (chronic renal insufficiency defined by creatinine clearance \< 30 ml/min according to the Cockcroft-Gault formula; platelets \< 100,000/mm3; active bleeding or high risk of bleeding (gastric ulcer, recent haemorrhagic stroke, etc.); known liver disease (Child Pugh class B and class C)).
13. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).
14. Refusal or inability to give written informed consent to participate in the study.
15. Life expectancy \< 6 months.
16. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice.
17. Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.

Primary outcomes:
measure: Presence of moderate to severe Post-thrombotic Syndrome (PTS)
timeFrame: 6 months
measure: Thrombosis burden
timeFrame: Baseline
Secondary outcomes:
measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline
timeFrame: 6 months
measure: Thrombosis burden adjusted to other prognostic factors at baseline
timeFrame: Baseline
measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up
timeFrame: Baseline, 1 week, 1 month, 3 months and 6 months
measure: Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up
timeFrame: Baseline, 1 week, 1 month, 3 months and 6 months
measure: Time to complete resolution of the thrombus as a function of thrombosis burden at baseline
timeFrame: up to 6 months
measure: Presence of moderate to severe PTS at baseline and at follow-up visits
timeFrame: Baseline, 1 week, 1 month, 3 months and 6 months
measure: Thrombosis burden at baseline and at follow-up visits
timeFrame: Baseline, 1 week, 1 month, 3 months and 6 months
Other outcomes:
measure: Disease specific health related quality of life
timeFrame: 3 months and 6 months
measure: General health related quality of life
timeFrame: 3 months and 6 months
measure: Coagulation and fibrinolysis markers
timeFrame: up to 3 months
measure: Fibrinolytic and pro-coagulant activities of microvesicles/microparticles
timeFrame: up to 3 months
Locations:
city: Carcassonne
country: France
facility: Centre Hospitalier de Carcassonne
state: Aude
city: Aubagne
country: France
facility: Hôpital d'Aubagne
state: Bouches-du-Rhône
city: Marseille
country: France
facility: Hôpital Saint Joseph
state: Bouches-du-Rhône
city: Marseille
country: France
facility: Hôpital La Timone, AP-HM
state: Bouches-du-Rhône
city: Martigues
country: France
facility: Cabinet libéral
state: Bouches-du-Rhône
city: Ajaccio
country: France
facility: Cabinet libéral
state: Corse-du-sud
city: Ajaccio
country: France
facility: Cabinet libéral
state: Corse-du-sud
city: Besançon
country: France
facility: CHU de Besançon
state: Doubs
city: Brest
country: France
facility: Centre Hospitalier Universitaire de Brest
state: Finistère
city: Toulouse
country: France
facility: Clinique Rive Gauche
state: Haut-Garonne
city: Montoir-de-Bretagne
country: France
facility: Centre de Santé Polyvalent de UGESSAP
state: Loire-Atlantique
city: Saint-Priest-en-Jarez
country: France
facility: CHU Saint Etienne
state: Loire
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital Edouard Herriot
state: Rhône
city: Amiens
country: France
facility: Centre Hospitalier Universitaire Amiens Picardie
state: Somme
city: Fréjus
country: France
facility: Centre Hospitalier de Fréjus/Saint-Raphaël
state: Var
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
state: Var
city: Saint-Raphaël
country: France
facility: Centre cardio-vasculaire Esterel
state: Var
city: Sanary-sur-Mer
country: France
facility: Cabinet libéral
state: Var
city: Six-Fours-les-Plages
country: France
facility: Cabinet libéral
state: Var
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
state: Var
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
state: Vaucluse
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Hôpital Saint Joseph
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer
name: Antoine ELIAS
role: STUDY_DIRECTOR
References: