Status:
COMPLETED
DULCIS (D-dimer and ULtrasonography in Combination Italian Study)
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
University of Bologna
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a standardized procedure to establish the optimal duration of anticoagulation in patients with venous thromboembolism.
Detailed Description
Venous thromboembolism (VTE- the deposition of thrombi in the deep veins of the lower limbs-deep vein thrombosis- and/or pulmonary embolism) has an incidence of 1.0 - 1.6 events per year per 1000 pers...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \> 18 years first episode of objectively documented symptomatic idiopathic VTE, either proximal lower extremity deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
- Unprovoked or idiopathic , or associated with one or more of the following favouring factors
- · - minor general surgery, arthroscopy or laparoscopy
- pregnancy or puerperium
- hormonal treatment (contraceptive or replacement therapy)
- travel
- minor traumas
- hospitalization in a medical ward
- reduced mobility (non complete immobilization) at least six months of VKA therapy ( or other type) for at least 3 months and not longer than 12 months ability to provide informed consent
- Exclusion criteria:
- Two or more episodes of objectively documented proximal DVT and or PE ( previous distal of superficial vein thrombosis are not exclusion criteria)
- Index event was isolate distal ( calf) vein thrombosis
- Index event was PE associated with shock or prolonged hypotension at high risk
- Index event was DVT in sites different from the lower limbs
- Pregnancy or puerperium ( first 6 weeks after delivery) at the time of the visit
- Solid or haematological malignancy in the active phase or undergoing chemotherapy or radiotherapy
- Antiphospholipid antibody syndrome, diagnosed according to the Sydney criteria
- Hereditary antithrombin deficiency
- Necessity to prolong anticoagulation for any reason (due to the thrombotic event or other clinical indications
- Severe respiratory or heart failure (NYHA classes: III or IV)
- Presence of criteria indicating a short anticoagulant treatment:
- Venous thromboembolism secondary to one of the following triggering factors:
- Major surgery \[orthopedic, general, oncological (only if radical)\]
- Bed rest (\>4 dd)
- Severe trauma
- Plaster cast of the lower limbs
- high bleeding risk
- limited life expectancy,
- geographical inaccessibility
- Inability or refusal to provide informed consent
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00954395
Start Date
September 1 2008
End Date
June 1 2012
Last Update
March 19 2021
Active Locations (1)
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1
U.O. Angiologia e Malattie della Coagulazione "Marino Golinelli"; Dipartimento Cardio-Toraco-Vascolare Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138