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

NCT ID: NCT00905216

Last Updated: 2011-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Test

Heparin sodium - Bergamo

Group Type: EXPERIMENTAL

heparin sodium - Bergamo

Intervention Type: DRUG

5.000 UI/mL

Comparator

Heparin APP

Group Type: ACTIVE_COMPARATOR

heparin sodium - APP

Intervention Type: DRUG

5.000 USP

Interventions

heparin sodium - Bergamo

5.000 UI/mL

Intervention Type: DRUG

heparin sodium - APP

5.000 USP

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clinica Pesquisa e Desenvolvimento Ltda

Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

alexandre Frederico, physician

Role: CONTACT

dr.alexandre@alclinica.com.br

55 19 3829-3822

Facility Contacts

Alexandre Frederico, Physician

Role: primary

dr.alexandre@alclinica.com.br

55 19 3829-3822

Other Identifiers

Heparin Bergamo

Identifier Type: -

Identifier Source: secondary_id

(Version 8)

Identifier Type: -

Identifier Source: secondary_id

HEPSBCCV0109_BER

Identifier Type: -

Identifier Source: org_study_id