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

Phase 3

• Conditions: Prevention of Venous Thromboembolism
• Interventions: Biological: bovine heparin; Biological: Porcine heparin

• Registration Number: NCT01072747
• Lead Sponsor: Azidus Brasil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Study Start: 2010-04
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-28
• Primary Completion: 2011-08
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
heparin of bovine origin	bovine heparin	Laboratory Bergamo Ltda. 5.000UI/mL bottle with 5mL
heparin of porcine origin	Porcine heparin	APP Pharmaceuticals

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil