Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients

Phase 3

Completed

• Conditions: Cardiac Surgery
• Interventions: Biological: Heparin sodium Hipolabor; Biological: Heparin sodium APP

• Registration Number: NCT00894673
• Lead Sponsor: Azidus Brasil

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-06
• Study First Posted: 2009-05-07
• Study Start: 2009-07
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Heparin sodium Hipolabor	Heparin sodium Hipolabor
2	Heparin sodium APP	Heparim Sodium APP 5.000 USP

Primary Outcome Measures

Name	Time	Method
Effectiveness of heparin of porcine origin in patients undergoing cardiovascular surgery	48 hours after 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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the average dose and and safety of porcine heparin.	48 hours after surgery.	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

Trial Locations

Locations (2)

Lal Clinica Pesquisa e Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil

LAL Clinica; 🇧🇷 Valinhos, SP, Brazil