Optimal Duration of Anticoagulation in Deep Venous Thrombosis

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in patients at their first episode of proximal deep venous thrombosis (DVT) of the lower extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal risk factors for thrombosis, with the help of an algorithm which incorporates both ultrasonography and D-dimer information. All patients will be followed-up until 1) the achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death; 4) the date of study stop. The purpose of this study is to demonstrate the safety of withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3 months). The approach will be deemed to be safe if the annual rate of recurrent VTE in patients who will have their anticoagulation discontinued is lower than 5%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Treatments: Anticoagulants; Fibrin fragment D; Vitamin K; Warfarin

Criteria

Inclusion Criteria:

• Patients with proximal DVT that is idiopathic or secondary to minor factors for thrombosis, with or without contemporary manifestations of PE, who have completed an uneventful 3 to 24-month period of anticoagulation and are available for an overall 48-month follow-up at the study centre.

Exclusion Criteria:

• previous thromboembolism

• recent (less than 3 months) major trauma or surgery

• active cancer

• immobilization resulting from chronic irreversible medical diseases

• need for indefinite anticoagulation for medical reasons other than VTE

• impossibility to attend the follow-up visits or to have D-dimer determinations

• already known major thrombophilia: carriage of deficiencies of natural anticoagulants, lupus-like anticoagulants, homozygosis for factor V Leiden or prothrombin mutation, heterozygosis for both abnormalities

• short (less than 1 year) life expectancy

• pregnancy

• age younger than 18

• refusal of informed consent