English Abstract
Journal Article
Randomized Controlled Trial
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[Two models of thromboprophylaxis in acutely ill medical inpatients].

INTRODUCTION: The risk of venous thromboembolism is equally high in medical patients admitted to the hospital and those treated in the surgery wards. Elderly people, who are immobilized due to heart failure, severe respiratory disease, ischemic stroke and cancer, represent patients at high risk of venous thrombosis. Current recommendations concerning antithrombotic prophylaxis do not specify the duration of prophylaxis in patients treated in the internal wards.

OBJECTIVES: The objective of this study was to evaluate the efficacy and safety of two models of thromboprophylaxis with nadroparin in medical inpatients hospitalized for acute illnesses.

PATIENTS AND METHODS: A total of 300 consecutive medical patients (155 M, 145 F, mean age, 67.8 +/- 4 years) were randomly assigned in an open-label study to two groups (1:1). Patients received thromboprophylaxis with nadroparin s.c. only during bed immobilization (the first group) or for 10 additional days (the second group). The follow-up lasted for three months after the end of thromboprophylaxis. Proximal deep veins thrombosis of lower limbs and death were considered as endpoints. Adverse effects of thromboprophylaxis were assessed, especially major bleedings and thrombocytopenia.

RESULTS: Both groups did not differ with regard to demographic characteristics or thrombotic risk factors. During a further 3-month follow-up of all the 300 patients, death of unknown causes or deep-vein thrombosis were found in 17 (5.6%) patients, including 2 patients who suddenly died. No such events were observed during the thromboprophylaxis period. In medical patients receiving thromboprophylaxis for a longer period of time than the immobilization there was a tendency to lower occurrence of death and deep-vein thrombosis within the first months following hospitalization (12 vs. 5; p = 0.08). There were no major bleedings or thrombocytopenia in both groups during thromboprophylaxis and the subsequent follow-up.

CONCLUSIONS: The study confirmed the effectiveness and safety of thromboprophylaxis with nadroparin in acutely ill medical inpatients, suggesting additional benefits from prolonged use of low molecular weight heparins observed during the first months after hospitalization.

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