Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia

• Status: Terminated
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G. d'Annunzio University
• Treatments: Fondaparinux; PENTA

Criteria

Inclusion Criteria:

• Age above 18 years;

• hospitalization in an Internal Medicine Unit and a Barbar score of 4 points or above

• Platelet count between 100,000/uL and 30,000/uL

• written informed consent

Exclusion Criteria:

• Active bleeding or bleeding within the previous 3 months;

• Known bleeding diathesis;

• Active gastroduodenal ulcer;

• Severe renal insufficiency defined by a creatinine clearance below 20 mL/min;

• Ongoing treatment with unfractionated heparin, low-moleculr-weight heparin, fondaparinux, or oral anticoagulants Trattamento in corso con eparina non

• Prophylaxis with unfractionated heparin, low-moleculr-weight heparin, or fondaparinux for more than 48 hours;

• double antiplatelet therapy or acetylsalicylic acid at daily doses above 165 mg;

• planned invasive procedure during the period of thromboprophylaxis;

• Hemoglobin values below 9 g/dL;

• AST or ALT above 2 times the uper limit of normal;

• pregnancy or breast feeding;

• life expectancy lower than 1 month