New strategy could spare patients from unnecessary blood thinners
NCT ID NCT03868956
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tested a new approach to diagnose whether a blood clot has returned in the leg. Instead of relying on older methods, doctors used color Doppler ultrasound and a D-Dimer blood test to safely rule out a new clot. Over 400 people with a history of deep vein thrombosis took part, and those not treated based on the strategy were followed for 3 months. The goal was to see if this method could avoid unnecessary blood thinner use while still catching dangerous clots.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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466 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Jan 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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APHM La Timone
Marseille, Bouches Du Rhône, 13385, France
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Cabinet libéral Ben Sedrine
Six-Fours-les-Plages, Var, 83140, France
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Cabinet libéral Besancon - polyclinique des Fleurs
Ollioules, Var, 83190, France
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Cabinet libéral Bonavita
Bastia, Haute-Corse, 20200, France
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Cabinet libéral Bourrinet
Balma, Haute-Garonne, 31130, France
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Cabinet libéral Casanova
Bastia, Haute Corse, 20600, France
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Cabinet libéral Cazaux
Auch, Gers, France
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Cabinet libéral De Mari
Ajaccio, Corse Du Sud, 20090, France
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Cabinet libéral Dias
Istres, Bouches-du-Rhône, 13800, France
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Cabinet libéral El Haddad
Marseille, Bouches-du-Rhône, 13011, France
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Cabinet libéral Esteve
Tarbes, Hautes-Pyrénées, 65000, France
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Cabinet libéral Pung
Aubagne, Bouches-du-Rhône, 13400, France
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Cabinet libéral Richard
Sanary-sur-Mer, Var, 83110, France
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Cabinet libéral Riviere
Six-Fours-les-Plages, Var, 83140, France
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Cabinet libéral Secondi
Ajaccio, Corse Du Sud, 20090, France
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Cabinet libéral Sidoli
Marseille, Bouches-du-Rhône, 13003, France
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Cabinet libéral Wagner
Lourdes, Hautes-Pyrénées, 65100, France
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Cabinet libéral Zimmermann
Six-Fours-les-Plages, Var, 83140, France
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Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056, France
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Centre Hospitalier Universitaire Bocage
Dijon, Cote d'Or, 21079, France
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Centre Hospitalier Universitaire François Mitterrand
Dijon, Côte d'Or, 21079, France
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Centre Hospitalier Universitaire Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
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Centre Hospitalier Universitaire Rangueil
Toulouse, Haute-Garonne, 31059, France
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Centre Hospitalier Universitaire d'Amiens
Amiens, Somme, 80054, France
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Centre Hospitalier Universitaire d'Angers
Angers, Maine-et-Loire, 49933, France
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Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, Puy-de-Dôme, 63000, France
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Centre Hospitalier Universitaire de Grenoble
Grenoble, Isère, 38700, France
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Centre Hospitalier Universitaire de Montpellier
Montpellier, Hérault, 34295, France
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Centre Hospitalier Universitaire de Nancy
Nancy, Meurthe Et Moselle, 54511, France
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Centre Hospitalier Universitaire de Nice
Nice, Alpes-Maritimes, 06001, France
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Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029, France
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Centre Hospitalier Universitaire de Rennes
Rennes, Ille-et-Vilaine, 35033, France
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Centre Hospitalier d'Auch
Auch, Gers, 32000, France
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Centre Hospitalier de Carcassonne
Carcassonne, Aude, 1060, France
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Centre Hospitalier de Vichy
Vichy, Allier, 03200, France
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Centre d'angiologie
Carcassonne, Aude, 11000, France
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Centre d'explorations vasculaires
Paris, Île-de-France Region, 75116, France
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Centre de medicine vasculaire interventionnel
Langon, Gironde, 33210, France
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Centre hospitalier Universitaire Cavale Blanche
Brest, Finistère, 29609, France
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Clinique Rive Gauche
Toulouse, Haute-Garonne, 31076, France
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Clinique des Fleurs
Ollioules, Var, 83190, France
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Espace Artois Santé
Arras, Pas-de-Calais, 62000, France
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Hôpital Edouard Herriot
Lyon, Rhône, 69003, France
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Hôpital Saint André
Bordeaux, Gironde, 33075, France
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Hôpital Saint Joseph
Paris, 75674, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can electronic alerts and patient teaching stop deadly clots after cancer surgery?
- A quick ultrasound in the ER: could it replace blood tests for blood clots?
- Simple 5-Step nursing plan could slash deadly clot risk after hip surgery
- Timing of blood thinners after childbirth bleeding may prevent clots without causing more harm
- New fingerstick test for blood thinner monitoring put to the test
- New Clot-Busting device could ease Long-Term leg pain