DVT Burden and the Risk of Post-thrombotic Syndrome

NCT06385353 | Recruiting

• 2 other identifiers: 2022-CHITS-0032023-A02652-43
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 27

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.

Conditions

Postthrombotic Syndrome

Keywords

Venous thrombosis; Thrombus burden; Ultrasonography; Thrombus resolution; Post-thrombotic syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Presence of moderate to severe PTS adjusted to other prognostic factors at baseline

  6 months

• Thrombosis burden adjusted to other prognostic factors at baseline

  Baseline

• 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

• Thrombosis burden adjusted to other prognostic factors at baseline and 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

Other Outcomes (4)

• Disease specific health related quality of life

  3 months and 6 months

• General health related quality of life

  3 months and 6 months

• Coagulation and fibrinolysis markers

  up to 3 months

Study Arms (1)

Association between thrombosis burden and occurrence of PTS

EXPERIMENTAL

Other: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome

Interventions

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.

Association between thrombosis burden and occurrence of PTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• History of ipsilateral or contralateral venous thrombosis of the lower limb.
• Fracture or orthopedic surgery of the lower limbs in the last 3 months.
• 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.
• Prophylactic or therapeutic anticoagulant treatment \> 5 days.
• Expected duration of anticoagulant treatment \< 3 months (all patients must have a minimum treatment of 3 months).
• Patient estimated at high risk of bleeding according to investigator clinical judgment (renal, platelet, digestive, hepatic, neurological... origin) .
• Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).
• Refusal or inability to give written informed consent to participate in the study.
• Life expectancy \< 6 months.
• Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice.
• Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Assistance Publique Hopitaux De Marseille: collaborator
• F-CRIN INNOVTE Research Network: collaborator

Study Sites (27)

CH de Vichy

Vichy, Allier, 03200, France

NOT YET RECRUITING

Centre Hospitalier de Carcassonne

Carcassonne, Aude, 11010, France

RECRUITING

Hôpital d'Aubagne

Aubagne, Bouches-du-Rhône, 13400, France

NOT YET RECRUITING

Hôpital Saint Joseph

Marseille, Bouches-du-Rhône, 13008, France

RECRUITING

Hôpital La Timone, AP-HM

Marseille, Bouches-du-Rhône, 13385, France

RECRUITING

Cabinet libéral

Martigues, Bouches-du-Rhône, 13500, France

TERMINATED

Cabinet libéral

Ajaccio, Corse-du-sud, 20090, France

RECRUITING

Cabinet libéral

Ajaccio, Corse-du-sud, 20090, France

RECRUITING

CHU de Dijon

Dijon, Côte d'Or, 21000, France

RECRUITING

CHU de Besançon

Besançon, Doubs, 25030, France

RECRUITING

Centre Hospitalier Universitaire de Brest

Brest, Finistère, 29069, France

RECRUITING

Clinique Rive Gauche

Toulouse, Haut-Garonne, 31076, France

RECRUITING

CHU de Toulouse

Toulouse, Haute-Garonne, 31400, France

NOT YET RECRUITING

Centre de Santé Polyvalent de UGESSAP

Montoir-de-Bretagne, Loire-Atlantique, 44550, France

TERMINATED

CHU Saint Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

RECRUITING

Hospices Civils de Lyon, Hôpital Edouard Herriot

Lyon, Rhône, 69003, France

RECRUITING

Centre Hospitalier Universitaire Amiens Picardie

Amiens, Somme, 830054, France

RECRUITING

Centre Hospitalier de Fréjus/Saint-Raphaël

Fréjus, Var, 83600, France

TERMINATED

Polyclinique Les Fleurs

Ollioules, Var, 83190, France

RECRUITING

Centre cardio-vasculaire Esterel

Saint-Raphaël, Var, 83700, France

WITHDRAWN

Cabinet libéral

Sanary-sur-Mer, Var, 83110, France

RECRUITING

Cabinet libéral

Six-Fours-les-Plages, Var, 83140, France

RECRUITING

Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer

Toulon, Var, 830054, France

RECRUITING

Centre Hospitalier d'Avignon

Avignon, Vaucluse, 84000, France

RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, 44000, France

RECRUITING

Hôpital Saint Joseph

Paris, 75014, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

NOT YET RECRUITING

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Antoine ELIAS

  Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer

  STUDY DIRECTOR

Central Study Contacts

Magali CESANA

CONTACT

0483772060; magali.cesana@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 26, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (27)