Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism
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To determine whether fondaparinux as monotherapy without warfarin is effective and safe for long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and data using fondaparinux.
Recurrent acute symptomatic DVT confirmed by venous ultrasound and/or CT scan [ Time Frame: 90 Days ]
Recurrent acute symptomatic PE confirmed by chest CT scan [ Time Frame: 90 Days ]
Major hemorrhage defined as spinal, retroperitoneal or intracranial bleeding, drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding [ Time Frame: 90 Days ]
Secondary Outcome Measures
Comparison of Day Zero, 6 week, and Day 90 platelet counts, renal function, hematocrit and transaminase level [ Time Frame: 90 Days ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Recurrent venous thromboembolism despite anticoagulation with warfarin(Or)
Clinically important bleeding complications due to warfarin(Or)
Inability to achieve the target INR on warfarin(Or)
Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or)
Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE
Require at least 90 days of anticoagulation
Require anticoagulation for objectively confirmed DVT and/or PE
Age greater than 18 years
Written informed consent
Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl
Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk.