Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia
Status:
Terminated
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous
thromboembolism in high risk medical patients. A relevant proportion of these patients have
renal insufficiency and/or thrombocytopenia which represent independent risk factors for
bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients
with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg
daily, has been approved for patients with renal insufficiency defined by a creatinine
clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies
that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical
patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate
the safety of fondaparinux in high risk hospitalized medical patients with a moderate to
severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.