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

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ClinicalTrials.gov Identifier: NCT00905216
Recruitment Status : Unknown
Verified January 2011 by Azidus Brasil.
Recruitment status was:  Recruiting
First Posted : May 20, 2009
Last Update Posted : January 28, 2011
Information provided by:
Azidus Brasil

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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: heparin sodium - Bergamo Drug: heparin sodium - APP Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
Study Start Date : June 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test
Heparin sodium - Bergamo
Drug: heparin sodium - Bergamo
5.000 UI/mL
Active Comparator: Comparator
Heparin APP
Drug: heparin sodium - APP
5.000 USP

Primary Outcome Measures :
  1. Comparison of TTPA, Anti-Xa and ACT Comparison of bleeding [ Time Frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative ]

Secondary Outcome Measures :
  1. adverse reactions [ Time Frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905216

Contact: alexandre Frederico, physician 55 19 3829-3822 dr.alexandre@alclinica.com.br

Lal Clinica Pesquisa E Desenvolvimento Ltda Recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Physician    55 19 3829-3822    dr.alexandre@alclinica.com.br   
Principal Investigator: alexandre Frederico, Physician         
Sponsors and Collaborators
Azidus Brasil

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT00905216     History of Changes
Other Study ID Numbers: HEPSBCCV0109_BER
Heparin Bergamo
(Version 8)
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011

Keywords provided by Azidus Brasil:

Additional relevant MeSH terms:
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action