Medical Patient, Thrombocytopenia
Conditions
Keywords
Fondaparinux, medical patient, vein thromboembolism, prophylaxis, thrombocytopenia
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.
Interventions
DRUGFondaparinux
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
Sponsors
G. d'Annunzio University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | All bleeding events that cannot be classified as major or clinically relevant non-major |
| 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 | 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 |
Countries
Italy
Outcome results
None listed