Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Major bleeding
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fondaparinux
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
Intervention: Fondaparinux (Drug)
Outcomes
Primary Outcomes
Major bleeding
Time Frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
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.
Secondary Outcomes
- Symptomatic venous thromboembolism(Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks)
- Clinically relevant non-major bleeding(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(Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks)
Investigators
Marcello Di Nisio
Principal Investigator
G. d'Annunzio University