The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
5.000UI/mL bottle with 5mL
5000 USP Heparin Units / mL vial with 10 mL vial
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
RECRUITINGCoagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa
Time frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.
Time frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
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