Efficacy and Safety of Sodium Heparin in Patients Submitted to Heart Surgery Using Bypass

Cardiac Surgery Clinical Trial

Official title:

Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00905216
• Other study ID #: HEPSBCCV0109_BER
• Secondary ID: Heparin Bergamo(
• Status: Recruiting
• Phase: Phase 3
• First received: May 5, 2009
• Last updated: January 27, 2011
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2011
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: alexandre Frederico, physician
• Phone: 55 19 3829-3822
• Email: dr.alexandre[@]alclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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 that require the aid of cardiopulmonary bypass. The effectiveness will be determined through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood (bleeding) at the end of the surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Extracorporeal.

Exclusion Criteria:

• Patients with hematological disorders that compromise the surgical changes (e.g., 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 (e.g., 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;

• Use of non-fractioned heparin for less than 12 hours.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• heparin sodium - Bergamo
5.000 UI/mL
• heparin sodium - APP
5.000 USP

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of TTPA, Anti-Xa and ACT Comparison of bleeding		Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative	No
Secondary	adverse reactions		Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative	Yes