Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.

Study Overview
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Brief Summary
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Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin

Official Title
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A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.

Conditions
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Thrombus

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Research that patients agreed to participate and signed the written informed consent; Patients aged over 18 years, both sexes, regardless of color or social class; Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system. Exclusion Criteria: Hypersensitivity to heparin sodium and / or benzyl alcohol; History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer; Severe liver disease; Cancer; Period of gestation; Genetic abnormality of the coagulation system; Multiple trauma; Use of aspirin in high doses (above 200mg per day); Use of glucocorticoids for at least 1 month; Use of other anticoagulants; Submission of a big surgery done less than 15 days; History of persistent hypertension at the end of dialysis than 150/100 mmHg; Indicated doses of heparin 20% above or below 150UI/kg.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Heparin - Hipolabor | Biological: Heparin sodium - Hipolabor<br>* Heparin 5000 IU / mL<br>|
| Active Comparator: Ative comparator<br>Heparin - APP | Biological: heparin sodium - APP<br>* Heparin 5000 IU / mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of heparin in thrombi formation. | During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin. | 12 consecutive sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration of the pharmacodynamic parameters. | During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA. | 12 consecutive sessions. | 
| Evaluation of Anti-Xa |  | 12 consecutive sessions (4 weeks - 3times/week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventing the thrombi formation