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Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients (HEPSBCCV0109)

This study has been completed.
Information provided by:
Azidus Brasil Identifier:
First received: May 5, 2009
Last updated: February 22, 2013
Last verified: February 2013
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 at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.

Condition Intervention Phase
Cardiac Surgery Biological: Heparin sodium Hipolabor Biological: 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:
  • Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery [ Time Frame: 48 hours after surgery. ]
    Patients undergoing cardiovascular surgery and who require the assistance of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of coagulation markers ACT, aPTT, anti-Xa heparin serum and excessive blood loss (hemorrhage ) after the final surgery.

Secondary Outcome Measures:
  • Evaluation of the average dose and and safety of porcine heparin. [ Time Frame: 48 hours after surgery. ]
    Evaluate the mean dose of heparin used in surgery and its relationship to the dose of protamine chloride and the need for blood transfusions and blood products during and after the process

Enrollment: 104
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Heparin sodium Hipolabor
Biological: Heparin sodium Hipolabor
Heparin sodium Hipolabor 5.000 UI/mL
Active Comparator: 2
Heparim Sodium APP 5.000 USP
Biological: Heparin sodium APP
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; AND
  • Extracorporeal.

Exclusion Criteria:

  • Patients with hematological disorders that compromise the surgical changes (eg 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 (eg 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; OR
  • Use of non-fractioned heparin for less than 12 hours.
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Please refer to this study by its identifier: NCT00894673

Lal Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270-000
LAL Clinica
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda. Identifier: NCT00894673     History of Changes
Other Study ID Numbers: HEPSBCCV0109_HIP
(Version 8)
Study First Received: May 5, 2009
Last Updated: February 22, 2013

Keywords provided by Azidus Brasil:
heparin cardiac surgery

Additional relevant MeSH terms:
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017