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

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00894673
First received: May 5, 2009
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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 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
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:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery [ Time Frame: 48 hours after surgery. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
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; 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894673

Locations
Brazil
Lal Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270-000
LAL Clinica
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT00894673     History of Changes
Other Study ID Numbers: HEPSBCCV0109_HIP, (Version 8)
Study First Received: May 5, 2009
Last Updated: February 22, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
heparin cardiac surgery

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013