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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Prevention of Venous Thromboembolism	Biological: Bovine Heparin; Biological: Porcine heparin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	104 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Prevention
Study Start Date :	April 2010
Estimated Primary Completion Date :	August 2010
Estimated Study Completion Date :	October 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: heparin of bovine origin; 5.000UI/mL bottle with 5mL	Biological: Bovine Heparin; 5.000UI/mL bottle with 5mL
Active Comparator: heparin of porcine origin; 5000 USP Heparin Units / mL vial with 10 mL vial	Biological: Porcine heparin; 5000 USP Heparin Units / mL vial with 10 mL vial

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine. [ Time Frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Alexandre Frederico, Dr.	+551938293822	alexandre@lalclinica.com.br

Locations

Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda	Recruiting
Valinhos, São Paulo, Brazil, 13276-245
Contact: Karina Guerra +551938293822 karina@lalclinica.com.br

Sponsors and Collaborators

Azidus Brasil

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier:	NCT01072955 History of Changes
Other Study ID Numbers:	HEPSBCCV1109BOV_EUR; version 2
First Posted:	February 22, 2010
Last Update Posted:	January 28, 2011
Last Verified:	January 2011

Additional relevant MeSH terms:

Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Calcium heparin	Heparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action