The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
5000UI/mL
5000UI/mL
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
TTPA Anti-Xa Adverse Reactions
Time frame: 12 consecutive sessions of hemodialysis
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