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Deep Vein ThrombosisULTRECNCT03868956

Diagnosis Exclusion of Recurrent Deep Vein Thrombosis of the Lower Limbs

A study testing Colour doppler ultrasound with or without D-dimer test in people with Deep Vein Thrombosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 45 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deep Vein Thrombosis
What is being tested?
Colour doppler ultrasound with or without D-dimer test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
466 participants
Where
45 sitesFrance
Study dates
17 Jan 2020to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
  • Delay from onset of symptoms to inclusion of more than 10 days
  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

France45 sites

  • Cabinet libéral De Mari

    Ajaccio, Corse Du Sud, 20090

  • Cabinet libéral Secondi

    Ajaccio, Corse Du Sud, 20090

  • Centre Hospitalier Universitaire d'Amiens

    Amiens, Somme, 80054

  • Centre Hospitalier Universitaire d'Angers

    Angers, Maine-et-Loire, 49933

  • Espace Artois Santé

    Arras, Pas-de-Calais, 62000

  • Cabinet libéral Pung

    Aubagne, Bouches-du-Rhône, 13400

  • Centre Hospitalier d'Auch

    Auch, Gers, 32000

  • Cabinet libéral Cazaux

    Auch, Gers

  • Cabinet libéral Bourrinet

    Balma, Haute-Garonne, 31130

  • Cabinet libéral Casanova

    Bastia, Haute Corse, 20600

  • Cabinet libéral Bonavita

    Bastia, Haute-Corse, 20200

  • Hôpital Saint André

    Bordeaux, Gironde, 33075

  • Centre hospitalier Universitaire Cavale Blanche

    Brest, Finistère, 29609

  • Centre Hospitalier de Carcassonne

    Carcassonne, Aude, 1060

  • Centre d'angiologie

    Carcassonne, Aude, 11000

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, Puy-de-Dôme, 63000

  • Centre Hospitalier Universitaire Bocage

    Dijon, Cote d'Or, 21079

  • Centre Hospitalier Universitaire François Mitterrand

    Dijon, Côte d'Or, 21079

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, Isère, 38700

  • Cabinet libéral Dias

    Istres, Bouches-du-Rhône, 13800

  • Centre de medicine vasculaire interventionnel

    Langon, Gironde, 33210

  • Cabinet libéral Wagner

    Lourdes, Hautes-Pyrénées, 65100

  • Hôpital Edouard Herriot

    Lyon, Rhône, 69003

  • APHM La Timone

    Marseille, Bouches Du Rhône, 13385

  • Cabinet libéral Sidoli

    Marseille, Bouches-du-Rhône, 13003

  • Cabinet libéral El Haddad

    Marseille, Bouches-du-Rhône, 13011

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, Hérault, 34295

  • Centre Hospitalier Universitaire de Nancy

    Nancy, Meurthe Et Moselle, 54511

  • Centre Hospitalier Universitaire de Nice

    Nice, Alpes-Maritimes, 06001

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, Gard, 30029

  • Cabinet libéral Besancon - polyclinique des Fleurs

    Ollioules, Var, 83190

  • Clinique des Fleurs

    Ollioules, Var, 83190

  • Hôpital Saint Joseph

    Paris, 75674

  • Centre d'explorations vasculaires

    Paris, Île-de-France Region, 75116

  • Centre Hospitalier Universitaire de Rennes

    Rennes, Ille-et-Vilaine, 35033

  • Centre Hospitalier Universitaire Nord

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

  • Cabinet libéral Richard

    Sanary-sur-Mer, Var, 83110

  • Cabinet libéral Ben Sedrine

    Six-Fours-les-Plages, Var, 83140

  • Cabinet libéral Riviere

    Six-Fours-les-Plages, Var, 83140

  • Cabinet libéral Zimmermann

    Six-Fours-les-Plages, Var, 83140

  • Cabinet libéral Esteve

    Tarbes, Hautes-Pyrénées, 65000

  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    Toulon, Var, 83056

  • Centre Hospitalier Universitaire Rangueil

    Toulouse, Haute-Garonne, 31059

  • Clinique Rive Gauche

    Toulouse, Haute-Garonne, 31076

  • Centre Hospitalier de Vichy

    Vichy, Allier, 03200

Other trials in France

About this study

Official title: Safety of a Management Strategy Based on Colour Doppler ULTrasound and D-Dimer Testing for the Diagnosis Exclusion of RECurrent Deep Vein Thrombosis of the Lower Limbs. The ULTREC Project

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.

Read more

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.

Read the detailed description

Venous thromboembolism (VTE) recurrence is a common situation after stopping anticoagulant treatment. This recurrence requires extended anticoagulant therapy to prevent thrombosis progression and embolization, but given an increased bleeding risk with prolonged treatment, an accurate diagnosis for VTE recurrence is needed.

Unfortunately, there is no reference standard for the diagnosis of deep vein thrombosis (DVT) recurrence and objective and accurate diagnostic methods are lacking. Clinical assessment does not allow discriminating between a previous and a recent thrombosis and there is no clinical prediction rule specific to the suspicion of DVT recurrence. D-dimer assays alone may not be able to safely exclude the diagnosis of DVT recurrence, and they have not been sufficiently validated in combination with clinical probability. The same holds for imaging modalities because normalisation rate after proximal DVT is low and a "residual thrombosis" may make difficult the diagnosis of a new thrombosis episode at the same site. Phlebography is non-diagnostic in 33% of cases. CT-venography has never been evaluated and MRI direct thrombus imaging (MRDTI) although very promising is still under evaluation.

As compression ultrasound (CUS) may be equivocal due to a residual thrombosis, a comparison to baseline measurements of residual vein diameter after full compression at the common femoral and the popliteal vein segments in cross-sectional plane has been suggested with an increase in diameter superior to 2 or 4 mm as a diagnosis criterion. This method has many major limitations related to: 1/the need for a previous measurement almost never available in practice, 2/ the potential for recurrence at a different site than that previously measured, 3/ a poor inter-observer agreement or at least inconsistent inter-observer variability between studies, 4/ small sample sizes in diagnostic accuracy and in diagnostic management studies and 5/ lack of external validation. Due to these limitations, recurrent ipsilateral DVT is mainly diagnosed by CUS when it occurs in a new or a normalised vein segment.

Colour Doppler ultrasound (CDUS) enables to study both the thrombus and the blood flow characteristics that might help to overcome the limitations of CUS and diameter measurements. Although CDUS has never been assessed for DVT recurrence in a study, it is used in every day clinical practice and seems very helpful. The diagnosis may be easily established using the same CDUS criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely exclude the diagnosis of recurrent DVT 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 (non-diagnostic) CDUS, a D-Dimer test is performed followed by repeat CDUS on D7±2 if D-dimer test result is abnormal. Meanwhile, patients are not treated by anticoagulants. A negative D-dimer test or an unchanged CDUS on D7±2 qualifies patients as free from a new DVT. Conversely a change in CDUS qualifies patients as having a new DVT. Only patients with a new DVT are treated. All patients have a 3-month follow-up for the assessment of venous thromboembolic and bleeding events by an independent adjudication committee.

Being tested
Colour doppler ultrasound with or without D-dimer test
Keywords
Deep vein thrombosis, Recurrence, Diagnostic strategy, Colour doppler ultrasound, D-dimer
Medical subject headings
Venous Thrombosis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colour doppler ultrasound with or without D-dimer testDiagnostic 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
Study groups in NCT03868956
Study groupRoleWhat they receive
Diagnostic strategyExperimentalColour doppler ultrasound (CDUS) with or without D-dimer test to rule-in or rule-out deep vein thrombosis recurrence
Receives: Diagnostic Test: Colour doppler ultrasound with or without D-dimer test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (6)

  1. Prevalence of deep vein thrombosis recurrence

    Proportion of patients with a new DVT among all patients included based on the results of the diagnostic tests used in the strategy and on the occurrence of VTE events during follow-up in patients untreated

    Measured: Up to 3 months

  2. Proportion of patients tested negative

    Proportion of patients tested negative by the strategy for DVT recurrence among all patients included

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

  3. Proportion of complete patients

    Proportion of patients who completed the strategy

    Measured: 3 months

  4. Bleeding complication occurrence

    The occurrence of bleeding complications will be assessed among all patients included during a 3-month follow-up period. The severity of these complications will be adjudicated by the independent clinical event committee according to the International Society on Thrombosis and Haemostasis classification criteria.

    Measured: 3 months

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

    Identification of clinical and ultrasound factors which could explain failure of the strategy in non anticoagulated patients

    Measured: 3 months

  6. Prevalence of isolated superficial vein thrombosis

    Proportion of patients with isolated superficial vein thrombosis during a 3-month follow-up among all patients included

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start17 Jan 2020
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03868956
Sponsor's protocol ID
2018-CHITS-04
Other IDs
2019-A00136-51
Acronym
ULTREC
Status last verified
Jul 2026
First submitted
8 Mar 2019
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.

    PubMed 23682905

  • Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4. doi: 10.1002/ajh.20754.

    PubMed 16947316

  • Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.

    PubMed 22315267

  • Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98. doi: 10.7326/0003-4819-136-2-200201150-00006.

    PubMed 11790060

  • Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340.

    PubMed 24615063

  • Goodacre S, Sampson F, Thomas S, van Beek E, Sutton A. Systematic review and meta-analysis of the diagnostic accuracy of ultrasonography for deep vein thrombosis. BMC Med Imaging. 2005 Oct 3;5:6. doi: 10.1186/1471-2342-5-6.

    PubMed 16202135

  • Hamadah A, Alwasaidi T, LE Gal G, Carrier M, Wells PS, Scarvelis D, Gonsalves C, Forgie M, Kovacs MJ, Rodger MA. Baseline imaging after therapy for unprovoked venous thromboembolism: a randomized controlled comparison of baseline imaging for diagnosis of suspected recurrence. J Thromb Haemost. 2011 Dec;9(12):2406-10. doi: 10.1111/j.1538-7836.2011.04533.x.

    PubMed 21985174

  • Hassen S, Barrellier MT, Seinturier C, Bosson JL, Genty C, Long A, Pernod G. High percentage of non-diagnostic compression ultrasonography results and the diagnosis of ipsilateral recurrent proximal deep vein thrombosis: a rebuttal. J Thromb Haemost. 2011 Feb;9(2):414-6; author reply 417-8. doi: 10.1111/j.1538-7836.2010.04137.x. No abstract available.

    PubMed 21070594

  • Heijboer H, Jongbloets LM, Buller HR, Lensing AW, ten Cate JW. Clinical utility of real-time compression ultrasonography for diagnostic management of patients with recurrent venous thrombosis. Acta Radiol. 1992 Jul;33(4):297-300.

    PubMed 1633039

  • Hull RD, Carter CJ, Jay RM, Ockelford PA, Hirsch J, Turpie AG, Zielinsky A, Gent M, Powers PJ. The diagnosis of acute, recurrent, deep-vein thrombosis: a diagnostic challenge. Circulation. 1983 Apr;67(4):901-6. doi: 10.1161/01.cir.67.4.901.

    PubMed 6825247

  • Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.

    PubMed 26867832

  • Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Perrier A, Bounameaux H. Value of D-dimer testing for the exclusion of pulmonary embolism in patients with previous venous thromboembolism. Arch Intern Med. 2006 Jan 23;166(2):176-80. doi: 10.1001/archinte.166.2.176.

    PubMed 16432085

  • Le Gal G, Kovacs MJ, Carrier M, Do K, Kahn SR, Wells PS, Anderson DA, Chagnon I, Solymoss S, Crowther M, Righini M, Perrier A, White RH, Vickars L, Rodger M. Validation of a diagnostic approach to exclude recurrent venous thromboembolism. J Thromb Haemost. 2009 May;7(5):752-9. doi: 10.1111/j.1538-7836.2009.03324.x. Epub 2009 Feb 18.

    PubMed 19228281

  • Linkins LA, Stretton R, Probyn L, Kearon C. Interobserver agreement on ultrasound measurements of residual vein diameter, thrombus echogenicity and Doppler venous flow in patients with previous venous thrombosis. Thromb Res. 2006;117(3):241-7. doi: 10.1016/j.thromres.2005.02.011. Epub 2005 Mar 21.

    PubMed 16378830

  • Prandoni P, Cogo A, Bernardi E, Villalta S, Polistena P, Simioni P, Noventa F, Benedetti L, Girolami A. A simple ultrasound approach for detection of recurrent proximal-vein thrombosis. Circulation. 1993 Oct;88(4 Pt 1):1730-5. doi: 10.1161/01.cir.88.4.1730.

    PubMed 8403319

Questions about this trial

What is this clinical trial studying?

A study testing Colour doppler ultrasound with or without D-dimer test in people with Deep Vein Thrombosis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 45 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjudicated symptomatic venous thromboembolic events (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03868956, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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