DVT Burden and the Risk of Post-thrombotic Syndrome

Not Applicable

Recruiting

• Conditions: Postthrombotic Syndrome
• Interventions: Other: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome

• Registration Number: NCT06385353
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-26
• Study Start: 2024-06-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Association between thrombosis burden and occurrence of PTS	Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome	-

Primary Outcome Measures

Name	Time	Method
Presence of moderate to severe Post-thrombotic Syndrome (PTS)	6 months	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	Baseline	Thrombosis burden is assessed using the Venous Volumetric Index (VVI) as well as prognostic factors at baseline.

Secondary Outcome Measures

Name	Time	Method
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up	Baseline, 1 week, 1 month, 3 months and 6 months	PTS is assessed at 6 months by the Villalta scale. Other prognostic factors related to anticoagulant therapy and compression are assessed during follow-up.
Presence of moderate to severe PTS adjusted to other prognostic factors at baseline	6 months	PTS is assessed at 6 months by the Villalta scale.
Thrombosis burden adjusted to other prognostic factors at baseline	Baseline	Thrombosis burden is assessed using the VVI index as well as prognostic factors at baseline.
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	Baseline, 1 week, 1 month, 3 months and 6 months	PTS is assessed by the Villalta scale.
Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up	Baseline, 1 week, 1 month, 3 months and 6 months	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.
Thrombosis burden at baseline and at follow-up visits	Baseline, 1 week, 1 month, 3 months and 6 months	The thrombus burden is assessed by the VVI index.

Trial Locations

Locations (18)

Hôpital d'Aubagne; 🇫🇷 Aubagne, Bouches-du-Rhône, France

Hôpital Saint Joseph; 🇫🇷 Paris, France

Hôpital La Timone, AP-HM; 🇫🇷 Marseille, Bouches-du-Rhône, France

CHU de Besançon; 🇫🇷 Besançon, Doubs, France

Centre de Santé Polyvalent de UGESSAP; 🇫🇷 Montoir-de-Bretagne, Loire-Atlantique, France

CHU Saint Etienne; 🇫🇷 Saint-Priest-en-Jarez, Loire, France

Centre Hospitalier de Carcassonne; 🇫🇷 Carcassonne, Aude, France

Cabinet libéral; 🇫🇷 Six-Fours-les-Plages, Var, France

Centre Hospitalier Universitaire de Brest; 🇫🇷 Brest, Finistère, France

Clinique Rive Gauche; 🇫🇷 Toulouse, Haut-Garonne, 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

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