The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
132
5000 UI/mL
5000 UI/mL
Instituto de Nefrologia de Campinas
Campinas, São Paulo, Brazil
Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis
Time frame: 4 weeks (12 consecutive sessions)
Pharmacodynamic activity of heparin observed through aPTT marker
Time frame: 4 weeks (sessions 1, 6 and 12)
Safety in use of heparin by monitoring adverse events
Time frame: 5 weeks (12 consecutive sessions + 1 post treatment session)
Marcelo A. C. Orlandi, Dr.
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