Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients

Cardiac Surgery Clinical Trial

— HEPSBCCV0109  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894673
• Other study ID #: HEPSBCCV0109_HIP
• Secondary ID: (Version 8)
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2009
• Last updated: February 22, 2013
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• 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; 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.

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

Biological:
• Heparin sodium Hipolabor
Heparin sodium Hipolabor 5.000 UI/mL
• Heparin sodium APP
Heparin sodium APP 5.000 USP

Locations

Country	Name	City	State
Brazil	LAL Clinica	Valinhos	SP
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	Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery	Patients undergoing cardiovascular surgery and who require the assistance of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of coagulation markers ACT, aPTT, anti-Xa heparin serum and excessive blood loss (hemorrhage ) after the final surgery.	48 hours after surgery.	No
Secondary	Evaluation of the average dose and and safety of porcine heparin.	Evaluate the mean dose of heparin used in surgery and its relationship to the dose of protamine chloride and the need for blood transfusions and blood products during and after the process	48 hours after surgery.	Yes