Diagnosis Exclusion of Recurrent Deep Vein Thrombosis of the Lower Limbs

NCT03868956 | Completed DMC

• 2 other identifiers: 2018-CHITS-042019-A00136-51
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 45

Brief Summary

The purpose is to assess the safety of a management strategy based on colour doppler ultrasound (CDUS) and D-Dimer test results for the diagnosis exclusion of recurrent deep vein thrombosis (DVT) of the lower limbs. DVT recurrence requires using anticoagulant treatment to prevent thrombosis progression. Given an increased bleeding risk with prolonged treatment, an accurate diagnosis for recurrence is needed. However, the diagnosis of a new thrombosis in a previously involved leg is difficult. Imaging modalities and criteria that are currently used for the diagnosis may be equivocal and unable to discriminate between an old clot and a new one recently developed at the same site. An increase in vein diameter after vein compression by the ultrasound probe was suggested as a diagnostic criterion for a new DVT. This method has many limitations in clinical practice, mainly a lack of availability of a previous measurement and a poor inter-observer agreement. Colour Doppler ultrasound enables to study both the thrombus and the blood flow characteristics that might help to overcome these limitations. CDUS is a well-known method for the diagnosis of vascular diseases and is used in every day clinical practice for the diagnosis of a first DVT and DVT recurrence but CDUS has never been assessed for DVT recurrence in a study. The diagnosis of DVT recurrence may be easily established using the same criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely rule out the diagnosis of DVT recurrence while maintaining a good specificity. The strategy consists in performing first a CDUS that helps to classify patients as having (positive CDUS) or not having (negative CDUS) a new thrombosis. In the case of an equivocal CDUS, a D-Dimer test is performed. If the D-dimer is normal, the diagnosis of DVT recurrence is ruled out and the patient is not treated. If the D-dimer is abnormal, the diagnosis cannot be excluded nor confirmed and a second CDUS is performed on D7±2. Meanwhile, patients are not treated by anticoagulants. An unchanged CDUS on D7±2 qualifies patients as free from a new DVT and they are not treated. Conversely a change in CDUS qualifies patients as having a new DVT which requires anticoagulant treatment. All patients have a 3-month follow-up for the assessment of potential venous thromboembolic events.

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis; Recurrence; Diagnostic strategy; Colour doppler ultrasound; D-dimer

Outcome Measures

Primary Outcomes (1)

• Adjudicated symptomatic venous thromboembolic events

  Rate of adjudicated symptomatic venous thromboembolic (VTE) events among patients not treated by anticoagulants according to the diagnostic strategy The criteria for recurrent VTE include: * objectively confirmed pulmonary embolism (PE) by either CT pulmonary angiography or ventilation-perfusion scan, * death due to PE, * and recurrent DVT of the leg Death, cause of death, VTE comprising isolated proximal or distal DVT and PE (with or without DVT), will be adjudicated by an independent clinical event committee blinded to the classification of the diagnostic strategy.

  3 months

Secondary Outcomes (6)

• Prevalence of deep vein thrombosis recurrence

  Up to 3 months

• Proportion of patients tested negative

  A day if the diagnostic strategy is conclusive (either positive or negative) at day 0, or 7 days if it is inconclusive

• Proportion of complete patients

  3 months

• Bleeding complication occurrence

  3 months

• Correlation of possible strategy failure in not anticoagulated patients and patient characteristics

  3 months

Study Arms (1)

Diagnostic strategy

EXPERIMENTAL

Colour doppler ultrasound (CDUS) with or without D-dimer test to rule-in or rule-out deep vein thrombosis recurrence

Diagnostic Test: Colour doppler ultrasound with or without D-dimer test

Interventions

Colour doppler ultrasound with or without D-dimer test DIAGNOSTIC_TEST

* Positive CDUS: anticoagulant treatment * Negative CDUS: no anticoagulant treatment * Non diagnostic CDUS : reference to routine D-dimer test * Negative test : no anticoagulant treatment * Positive test : second CDUS 7 days (±2) after first one * No change in CDUS : no anticoagulant treatment * Change in CDUS : anticoagulant treatment

Diagnostic strategy

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
• Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
• Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb i.e. the occurrence of new symptoms and signs of DVT or the increase of symptoms and signs in patients with post-thrombotic syndrome
• Patients covered by social security or equivalent regimen
• Signed and dated informed consent

You may not qualify if:

• Known current pregnancy
• Any condition, which, in the opinion of the investigator may prevent him from performing the colour doppler ultrasound test (plaster cast, inaccessible vein segment after abdominal or pelvic surgery, or other causes that may lead to a technically inadequate CDUS)
• Therapeutic anticoagulation for more than 48 hours in the two days prior to consent or a need for long term anticoagulation
• Prophylactic anticoagulation for more than 48 hours in the two days prior to consent
• Clinical symptoms of pulmonary embolism
• Life expectancy less than 3 months
• Patient unable to adhere to protocol or follow-up visits and contacts
• Participants under legal guardianship or incapacitation
• Patient already enrolled in a deep vein thrombosis (DVT) diagnostic research

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Centre Hospitalier Universitaire de Saint Etienne: collaborator
• Investigation network on venous thrombo-embolism: collaborator

Study Sites (45)

Centre Hospitalier de Vichy

Vichy, Allier, 03200, France

Location

Centre Hospitalier Universitaire de Nice

Nice, Alpes-Maritimes, 06001, France

Location

Centre Hospitalier de Carcassonne

Carcassonne, Aude, 1060, France

Location

Centre d'angiologie

Carcassonne, Aude, 11000, France

Location

APHM La Timone

Marseille, Bouches Du Rhône, 13385, France

Location

Cabinet libéral Pung

Aubagne, Bouches-du-Rhône, 13400, France

Location

Cabinet libéral Dias

Istres, Bouches-du-Rhône, 13800, France

Location

Cabinet libéral Sidoli

Marseille, Bouches-du-Rhône, 13003, France

Location

Cabinet libéral El Haddad

Marseille, Bouches-du-Rhône, 13011, France

Location

Cabinet libéral De Mari

Ajaccio, Corse Du Sud, 20090, France

Location

Cabinet libéral Secondi

Ajaccio, Corse Du Sud, 20090, France

Location

Centre Hospitalier Universitaire Bocage

Dijon, Cote d'Or, 21079, France

Location

Centre Hospitalier Universitaire François Mitterrand

Dijon, Côte d'Or, 21079, France

Location

Centre hospitalier Universitaire Cavale Blanche

Brest, Finistère, 29609, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Centre Hospitalier d'Auch

Auch, Gers, 32000, France

Location

Cabinet libéral Cazaux

Auch, Gers, France

Location

Hôpital Saint André

Bordeaux, Gironde, 33075, France

Location

Centre de medicine vasculaire interventionnel

Langon, Gironde, 33210, France

Location

Cabinet libéral Casanova

Bastia, Haute Corse, 20600, France

Location

Cabinet libéral Bonavita

Bastia, Haute-Corse, 20200, France

Location

Cabinet libéral Bourrinet

Balma, Haute-Garonne, 31130, France

Location

Centre Hospitalier Universitaire Rangueil

Toulouse, Haute-Garonne, 31059, France

Location

Clinique Rive Gauche

Toulouse, Haute-Garonne, 31076, France

Location

Cabinet libéral Wagner

Lourdes, Hautes-Pyrénées, 65100, France

Location

Cabinet libéral Esteve

Tarbes, Hautes-Pyrénées, 65000, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, Hérault, 34295, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, Ille-et-Vilaine, 35033, France

Location

Centre Hospitalier Universitaire de Grenoble

Grenoble, Isère, 38700, France

Location

Centre Hospitalier Universitaire d'Angers

Angers, Maine-et-Loire, 49933, France

Location

Centre Hospitalier Universitaire de Nancy

Nancy, Meurthe Et Moselle, 54511, France

Location

Espace Artois Santé

Arras, Pas-de-Calais, 62000, France

Location

Centre Hospitalier Universitaire Nord

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, Puy-de-Dôme, 63000, France

Location

Hôpital Edouard Herriot

Lyon, Rhône, 69003, France

Location

Centre Hospitalier Universitaire d'Amiens

Amiens, Somme, 80054, France

Location

Cabinet libéral Besancon - polyclinique des Fleurs

Ollioules, Var, 83190, France

Location

Clinique des Fleurs

Ollioules, Var, 83190, France

Location

Cabinet libéral Richard

Sanary-sur-Mer, Var, 83110, France

Location

Cabinet libéral Ben Sedrine

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

Location

Cabinet libéral Riviere

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

Location

Cabinet libéral Zimmermann

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

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location

Hôpital Saint Joseph

Paris, 75674, France

Location

Centre d'explorations vasculaires

Paris, Île-de-France Region, 75116, France

Location

Related Publications (24)

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MeSH Terms

Conditions

Venous Thrombosis; Recurrence

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine Elias, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: January 17, 2020
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (45)