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

NCT00905216 | Unknown Phase 3

• 3 other identifiers: HEPSBCCV0109_BERHeparin Bergamo(Version 8)
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Keywords

heparin

Outcome Measures

Primary Outcomes (1)

• Comparison of TTPA, Anti-Xa and ACT Comparison of bleeding

  Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative

Secondary Outcomes (1)

• adverse reactions

  Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative

Study Arms (2)

Test

EXPERIMENTAL

Heparin sodium - Bergamo

Drug: heparin sodium - Bergamo

Comparator

ACTIVE COMPARATOR

Heparin APP

Drug: heparin sodium - APP

Interventions

heparin sodium - Bergamo DRUG

5.000 UI/mL

Test

heparin sodium - APP DRUG

5.000 USP

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

RECRUITING

Central Study Contacts

alexandre Frederico, physician

CONTACT

55 19 3829-3822; dr.alexandre@alclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 20, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2011
• Last Updated: January 28, 2011

Record last verified: 2011-01

Locations

BR (1)