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

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

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 Overview

• Status: Unknown
• Conditions: Prevention of Venous Thromboembolism
• Intervention / Treatment: Biological: bovine heparin; Biological: Porcine heparin

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270000
      • Recruiting
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: February 19, 2010
• First Posted (Estimate): February 22, 2010

Study Record Updates

• Last Update Posted (Estimate): January 28, 2011
• Last Update Submitted That Met QC Criteria: January 27, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: HEPSBCCV1109BOV_BER