Prevention of Venous Thromboembolism
Conditions
Brief summary
The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory 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.
Interventions
BIOLOGICALBovine Heparin
5.000UI/mL bottle with 5mL
BIOLOGICALPorcine heparin
5000 USP Heparin Units / mL vial with 10 mL vial
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who agree with all aspects of the study and sign the FICT; * Patients of both sexes; * Patients over the age of 18 years; * Patients with indication for cardiac surgery requiring cardiopulmonary bypass.
Exclusion criteria
* Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb \<11.0 g / dL, platelets \<100,000 mm3); * Patients with disorders of hemostasis (INR\> 1.40) (APTTr\> 1.40); * Patients with renal impairment (creatinine\> 1.50); * Patients with deep hyperthermia; * Liver disease (AST and ALT\> 2 times that of the reference value); * Patients with a history of allergy to heparin or protamine; * Patients with a history of heparin-induced thrombocytopenia; * infection (eg endocarditis, septicemia and pneumonia); * Reoperations; * Use of antiplatelet agents (clopidogrel and ticlopidine) for less than 7 days; * Use of aspirin for less than 5 days; * Use of heparin, low molecular weight less than 24 hours; * Use of unfractionated heparin for less than 12 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa | (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine. | (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative |
Countries
Brazil
Contacts
Primary ContactAlexandre Frederico, Dr.
Outcome results
None listed