Randomized, Blind and Comparative Clinical Trial of Efficacy and Security of Unfractioned Heparin Sodium of Bovine Origin in Patients Submitted to Cardiovascular Surgery With Cardiopulmonary Bypass

Azidus Brasil1 site in 1 country104 target enrollmentApril 2010

ConditionsPrevention of Venous Thromboembolism

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Prevention of Venous Thromboembolism
Sponsor: Azidus Brasil
Enrollment: 104
Locations: 1
Primary Endpoint: Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

November 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azidus Brasil

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Coagulometric 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

Secondary Outcomes

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)