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

NCT01072955 | Unknown Phase 3

• 2 other identifiers: HEPSBCCV1109BOV_EURversion 2
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory 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.

Conditions

Prevention of Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa

  (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative

Secondary Outcomes (1)

• Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.

  (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative

Study Arms (2)

heparin of bovine origin

EXPERIMENTAL

5.000UI/mL bottle with 5mL

Biological: Bovine Heparin

heparin of porcine origin

ACTIVE COMPARATOR

5000 USP Heparin Units / mL vial with 10 mL vial

Biological: Porcine heparin

Interventions

Bovine Heparin BIOLOGICAL

5.000UI/mL bottle with 5mL

heparin of bovine origin

Porcine heparin BIOLOGICAL

5000 USP Heparin Units / mL vial with 10 mL vial

heparin of porcine origin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13276-245, Brazil

RECRUITING

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Alexandre Frederico, Dr.

CONTACT

+551938293822; alexandre@lalclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2011
• Last Updated: January 28, 2011

Record last verified: 2011-01

Locations

BR (1)