PROLONG Study

D-Dimer Test to Establish Duration of Anticoagulation After a First Idiopathic Episode of Venous Thromboembolism; the Prospective Randomized “Prolong” Study

The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation. The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients.

St. Orsola Hospital

The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00264277.

The previous information was derived from ClinicalTrials.gov on 09/25/2013 using the identification number NCT00264277.

• Age > 18 years
• After a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism
• After at least 3 months of oral anticoagulation
• After written informed consent

• If the Venous thromboembolism occurred:
  • During pregnancy or puerperium
  • After recent (i.e. within three months) fracture or plaster casting of a leg,
  • After immobilization with confinement to bed for three consecutive days
  • After surgery with general anesthesia lasting longer than 30 minutes
• Patients with:
  • Active cancer
  • Antiphospholipid antibody syndrome
  • Antithrombin deficiency
  • Serious liver disease or renal insufficiency (creatininemia > 2 mg/dL),
  • Other indications for anticoagulation or contraindications for this treatment
  • Limited life expectation
• Patients who live too far from the clinical center

• Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up
• Confirmed major bleeding events at 18 months follow up

Not provided

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