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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Azidus Brasil.
Recruitment status was:  Recruiting
Information provided by:
Azidus Brasil Identifier:
First received: May 5, 2009
Last updated: January 27, 2011
Last verified: January 2011
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 Intervention Phase
Cardiac Surgery Drug: heparin sodium - Bergamo Drug: heparin sodium - APP Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Azidus Brasil:

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

Estimated Enrollment: 104
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00905216

Contact: alexandre Frederico, physician 55 19 3829-3822

Lal Clinica Pesquisa E Desenvolvimento Ltda Recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Physician    55 19 3829-3822   
Principal Investigator: alexandre Frederico, Physician         
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda Identifier: NCT00905216     History of Changes
Other Study ID Numbers: HEPSBCCV0109_BER
Heparin Bergamo
(Version 8)
Study First Received: May 5, 2009
Last Updated: January 27, 2011

Keywords provided by Azidus Brasil:

Additional relevant MeSH terms:
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017