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Efficacy and Safety of Sodium Heparin (Eurofarma)

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00894829
First received: May 5, 2009
Last updated: February 22, 2013
Last verified: February 2013
  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 - Eurofarma
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:


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

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 ] [ Designated as safety issue: No ]
  • 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 ]

Enrollment: 104
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Heparin sodium - Eurofarma
Biological: heparin sodium - Eurofarma
Heparin sodium 5.000 UI - Eurofarma
Active Comparator: 2
Heparin APP
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
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: NCT00894829

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13276-245
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT00894829     History of Changes
Other Study ID Numbers: HEPSBCCV0109_EUR, Heparin Eurofarma (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
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014