Status:
TERMINATED
D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than...
Eligibility Criteria
Inclusion
- Patients with at least two episodes of objectively documented venous thromboembolism (at least one proximal deep vein thrombosis or pulmonary embolism)
- Ongoing treatment with oral anticoagulants for at least a) 12 months in case idiopathic DVT was the last event; b) 6 months in all other cases
- Age \> 18 years
- Informed consent provided
Exclusion
- Pregnancy/puerperium
- One or more episodes of massive pulmonary embolism
- Last event isolated idiopathic pulmonary embolism
- Two or more idiopathic VTE events
- First degree relatives with recurrent VTE
- Right ventricular disfunction or pulmonary hypertension
- Active cancer
- Antiphospholipid antibodies syndrome
- Antithrombin deficiency
- Homozygous Factor V Leiden or G20210A prothrombin mutation
- Heterozygous Factor V Leiden and G20210A prothrombin mutation
- Concomitant congenital thrombophilic mutations
- Concomitant indications to long term oral anticoagulant treatment
- Severe cardiorespiratory insufficiency
- Severe liver or renal disease (creatinine clearance \> 2 mg/dL)
- Limited life expectancy
- Geographic inaccessibility
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00428441
Start Date
May 1 2007
End Date
May 1 2011
Last Update
September 26 2011
Active Locations (1)
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1
University Of Insubria
Varese, Italy, 21100