Status:
COMPLETED
Diagnosis Exclusion of Recurrent Deep Vein Thrombosis of the Lower Limbs
Lead Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborating Sponsors:
Centre Hospitalier Universitaire de Saint Etienne
Investigation network on venous thrombo-embolism
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 embo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT03868956
Start Date
January 17 2020
End Date
January 30 2023
Last Update
November 20 2025
Active Locations (45)
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1
Centre Hospitalier de Vichy
Vichy, Allier, France, 03200
2
Centre Hospitalier Universitaire de Nice
Nice, Alpes-Maritimes, France, 06001
3
Centre Hospitalier de Carcassonne
Carcassonne, Aude, France, 1060
4
Centre d'angiologie
Carcassonne, Aude, France, 11000