Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Biological: Heparin sodium Hipolabor
* Biological: Heparin sodium APP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Heparin sodium Hipolabor | Biological: Heparin sodium Hipolabor<br>* Heparin sodium Hipolabor 5.000 UI/mL<br>|
| Active Comparator: 2<br>Heparim Sodium APP 5.000 USP | Biological: Heparin sodium APP<br>* Heparin sodium APP 5.000 USP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin cardiac surgery