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Efficacy and Safety of Sodium Heparin

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ClinicalTrials.gov Identifier: NCT00894985
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : February 25, 2013
Sponsor:
Information provided by:
Azidus Brasil

Brief Summary:
The objective of this study is to verify, through a randomized, open, 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 or disease Intervention/treatment Phase
Cardiac Surgery Biological: heparin sodium - blausiegel Biological: heparin sodium - APP Phase 3

Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Heparin 5.000UI
Biological: heparin sodium - blausiegel
heparin sodium 5.000UI
Active Comparator: 2
Heparin 5.000USP - APP
Biological: heparin sodium - APP
heparin sodium 5.000 USP - APP



Primary Outcome Measures :
  1. Comparison of TTPA, Anti-Xa and ACT [ Time Frame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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; 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.

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): NCT00894985


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

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT00894985     History of Changes
Other Study ID Numbers: HEPSBCCV0109_BLA2
Heparin Blausiegel 2
(Version 8)
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013

Keywords provided by Azidus Brasil:
heparin cardiac surgery

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