Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure

Study Overview
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Brief Summary
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The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.

Official Title
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Clinical Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Biological: Heparin sodic - Cristália
* Biological: heparin - Liquemine (Roche)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults of both sexes, regardless of color or social class Age over 18 years with a good clinical medical criteria Patients who agreed to participate and signed the Informed Consent Insufficient patients in chronic renal dialysis schedule (3 times per week) Patients with creatinine clearance <30ml/min Patients with indication for anticoagulation during hemodialysis Exclusion Criteria: Patients with sensitivity to heparin sodium; Patients with hypersensitivity to benzyl alcohol Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer Patients with a history of peptic ulcer Patients with body mass index greater than 30 Cancer patients because of the possibility of compromising the function of the variable coagulation Patients in period of pregnancy or after delivery Patients with genetic abnormality of the clotting system Polytraumatized patients Patients using glucocorticoids for at least 1 month Patients using other anticoagulants Patients with high rate of bleeding Patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery Hypertension above 140/90 mmHg Patients using medications that could affect hemostasis Patients using the following medicines: hormonal anti not including Ketorolac; Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Heparin Cristália | Biological: Heparin sodic - Cristália<br>* 5000UI/mL<br>|
| Active Comparator: 2<br>Heparin - Roche | Biological: heparin - Liquemine (Roche)<br>* 5000UI/mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTPA Anti-Xa Adverse Reactions |  | 12 consecutive sessions of hemodialysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TTPa, Anti-Xa, Adverse Reactions