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

Study Overview
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Brief Summary
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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.

Official Title
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Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia

Conditions
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Medical Patient, Thrombocytopenia

Intervention / Treatment
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* Drug: Fondaparinux


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fondaparinux<br>Drug: fondaparinux once daily sc injections 2.5 mg if renal clearance of creatinine above 50 ml/min once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min | Drug: Fondaparinux<br>* Fondaparinux once daily sc injections at a dose of 2.5 mg if renal clearance of creatinine above 50 ml/min or Fondaparinux once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min<br>* Other names: Arixtra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death. | Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically relevant non-major bleeding | clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life. | Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks | 
| Minor Bleeding | All bleeding events that cannot be classified as major or clinically relevant non-major | Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks | 
| Symptomatic venous thromboembolism | Deep vein thrombosis will be confirmed by compression ultrasonography or venography. Pulmonary embolism will be confirmed by spiral computed tomography or V/Q lung scan | Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fondaparinux, medical patient, vein thromboembolism, prophylaxis, thrombocytopenia