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

Azidus

Status and phase: Unknown; Phase 3

Conditions: Prevention of Venous Thromboembolism

Treatments: Biological: Bovine Heparin; Biological: Porcine heparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01072955

HEPSBCCV1109BOV_EUR

version 2

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

heparin of bovine origin

Experimental group

Description:

5.000UI/mL bottle with 5mL

Treatment:

Biological: Bovine Heparin

heparin of porcine origin

Active Comparator group

Description:

5000 USP Heparin Units / mL vial with 10 mL vial

Treatment:

Biological: Porcine heparin