Often it is necessary to temporarily discontinue OAT when surgical or other invasive procedures are required. However, there is no consensus on the optimal management in these situations, and heparin bridging therapy is the current usual practice in these situations. No large randomized, controlled clinical trials have been yet performed to evaluate the efficacy and safety of a low molecular weight heparins (LMWH) as bridging therapy.
THE MAIN OBJECTIVE of this study is to evaluate the efficacy and safety of the subcutaneous administration of Bemiparin 3,500 IU, for the peri-operative procedural management of patients requiring temporary interruption of oral anticoagulation therapy (OAT). PRIMARY EFFICACY ENDPOINT: combined incidence of arterial and venous thromboembolic events and deaths from any causes within 3 months after the invasive procedure. PRIMARY SAFETY ENDPOINT: incidence of major bleeding within 10 days after the invasive procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
3.500 UI/día.
10.000 UI/día.
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Hospital General de Alicante
Alicante, Alicante, Spain
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Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau
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L'Hospitalet de Llobregat, Barcelona, Spain
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...and 21 more locations