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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
Sponsor:
Information provided by:
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT00905216
First received: May 5, 2009
Last updated: January 27, 2011
Last verified: January 2011
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00905216

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
  More Information

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) 
Study First Received: May 5, 2009
Last Updated: January 27, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Azidus Brasil:
heparin

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

ClinicalTrials.gov processed this record on December 07, 2016