Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
342
Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days
Unnamed facility
Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment
Time frame: 10 ± 2 days
Thromboembolic events during follow-up period of 3 months
Time frame: 90 days (± 7 days) after the end of the treatment
Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies
Time frame: 10 ± 2 days
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