Efficacy And Safety Of Unfractionated Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Prevention of Venous Thromboembolism

Intervention / Treatment
-----------------
* Biological: bovine heparin
* Biological: Porcine heparin


Participation Criteria
=================
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; 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: heparin of bovine origin<br>Laboratory Bergamo Ltda. 5.000UI/mL bottle with 5mL | Biological: bovine heparin<br>* 5.000UI/mL bottle with 5mL<br>|
| Active Comparator: heparin of porcine origin<br>APP Pharmaceuticals | Biological: Porcine heparin<br>* 5000 USP Heparin Units / mL vial with 10 mL vial<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |