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

Prevention of Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01072747
• Other study ID #: HEPSBCCV1109BOV_BER
• Status: Recruiting
• Phase: Phase 3
• First received: February 19, 2010
• Last updated: January 27, 2011
• Start date: April 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2011
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: Alexandre Frederico, Physician
• Phone: 55 19 3829-3822
• Email: alexandre[@]lalclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prevention of Venous Thromboembolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Biological:
• bovine heparin
5.000UI/mL bottle with 5mL
• Porcine heparin
5000 USP Heparin Units / mL vial with 10 mL vial

Locations

Country	Name	City	State
Brazil	LAL Clinica Pesquisa e Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No