Efficacy And Safety Of Unfractionated Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01072747
First received: February 19, 2010
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.


Condition Intervention Phase
Prevention of Venous Thromboembolism
Biological: bovine heparin
Biological: Porcine heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Blind and Comparative Clinical Trial of Efficacy and Security of Unfractioned Heparin Sodium of Bovine Origin in Patients Submitted to Cardiovascular Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa [ Time Frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine. [ Time Frame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: April 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: heparin of bovine origin
Laboratory Bergamo Ltda. 5.000UI/mL bottle with 5mL
Biological: bovine heparin
5.000UI/mL bottle with 5mL
Active Comparator: heparin of porcine origin
APP Pharmaceuticals
Biological: Porcine heparin
5000 USP Heparin Units / mL vial with 10 mL vial

  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 over the age of 18 years;
  • Patients with indication for cardiac surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

  • Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb <11.0 g / dL, platelets <100,000 mm3);
  • Patients with disorders of hemostasis (INR> 1.40) (APTTr> 1.40);
  • Patients with renal impairment (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 a history of heparin-induced thrombocytopenia;
  • infection (eg endocarditis, septicemia and pneumonia);
  • Reoperations;
  • Use of antiplatelet agents (clopidogrel and ticlopidine) for less than 7 days;
  • Use of aspirin for less than 5 days;
  • Use of heparin, low molecular weight less than 24 hours;
  • Use of unfractionated 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: NCT01072747

Contacts
Contact: Alexandre Frederico, Physician 55 19 3829-3822 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda Recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Physician    55 19 3829-3822    alexandre@lalclinica.com.br   
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Dr. Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT01072747     History of Changes
Other Study ID Numbers: HEPSBCCV1109BOV_BER
Study First Received: February 19, 2010
Last Updated: January 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Calcium heparin
Heparin
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
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 October 20, 2014