Pharmacodynamics Clinical Trial
1. Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is
an endogenous anticoagulant. This complex inhibits the formation of thrombin and
accelerates its destruction. In addition, heparin and ATIII inactivate other proteases
of the coagulation cascade, especially the anti-activated factor X. The outcome of
these biochemical actions is the inhibition of the formation and synthesis of
activators of the clotting factors that exert critical functions in the genesis of the
blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis
need a system of anticoagulation with direct inhibitors of thrombin and / or
heparinoids to prevent thrombosis.
Based on clinical studies, the control of plasma heparin level in patients with CRF is
essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa
factor to be used as a substrate for protection for those patients undergoing
hemodialysis.
2. Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in
use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having
as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in
patients with renal failure who do hemodialysis treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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