Efficacy and Safety of Sodium Heparin in Patients Submitted to Heart Surgery Using Bypass

Azidus

Status and phase: Unknown; Phase 3

Conditions: Cardiac Surgery

Treatments: Drug: heparin sodium - APP; Drug: heparin sodium - Bergamo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905216

(Version 8)

HEPSBCCV0109_BER

Heparin Bergamo

Details and patient eligibility

About

The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery that require the aid of cardiopulmonary bypass. The effectiveness will be determined through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood (bleeding) at the end of the 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 aged above 18 years;
• Patients with cardiac surgery and requiring movement Extracorporeal.

Exclusion criteria

• Patients with hematological disorders that compromise the surgical changes (e.g., myeloproliferative syndromes, anemia Hb < 11.0 g/dL,
• Platelets < 150,000 mm3);
• Patients with disorders of hemostasis (INR > 1.40) (rTTPA > 1.40);
• Patients with renal dysfunction (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 history of heparin-induced thrombocytopenia;
• Tables infection (e.g., endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
• Reoperations;
• Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
• Use of acetylsalicylic acid is less than 5 days;
• Use of low molecular weight heparin for less than 24 hours;
• Use of non-fractioned 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

Test

Experimental group

Description:

Heparin sodium - Bergamo

Treatment:

Drug: heparin sodium - Bergamo

Comparator

Active Comparator group

Description:

Heparin APP

Treatment:

Drug: heparin sodium - APP