We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Sodium Heparin in Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894959
First Posted: May 7, 2009
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Azidus Brasil
  Purpose
The objective of this study is 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 Blausiegel 1 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:
  • 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 ]
  • 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 ]

Enrollment: 104
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Heparin Sodium Blausiegel 1
Biological: Heparin sodium Blausiegel 1
Heparin sodium Blausiegel 1 5.000 UI
Experimental: Active Comparator
heparin sodium - APP 5.000 USP
Biological: Heparin sodium APP
Heparin sodium APP 5.000 USP

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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): NCT00894959


Locations
Brazil
LAL clinica pesquisa e desenvolvimento ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT00894959     History of Changes
Other Study ID Numbers: HEPSBCCV0109_BLA1
Heparin Blausiegel 1
(Version 8)
First Submitted: May 5, 2009
First Posted: May 7, 2009
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