Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was Not yet recruiting
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
First received: December 16, 2009
Last updated: January 27, 2011
Last verified: January 2011
Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis.
Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis.
- Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Primary Outcome Measures:
- Effect (activity) of heparin observed for markers for aPTT and anti-Xa. [ Time Frame: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effectiveness in maintaining the absence clotting during hemodialysis. [ Time Frame: 12 consecutive sessions ] [ Designated as safety issue: No ]
- Safety in use of the drug by monitoring events complicating the use of heparin [ Time Frame: 12 consecutive sessions ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Active Comparator: Heparin sodium - APP
5000UI / mL
Experimental: Heparin - Eurofarma
5000 UI/ mL
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Adults of both sexes, regardless of color or social class;
- Age over 18 years, with good clinical doctor's discretion;
- Patients research that agree to participate in the study and sign the informed consent form (attached);
- Chronic renal failure patients in hemodialysis (3 times per week). chronic renal failure patients with indication for anticoagulation during dialysis
- Non compliance with the terms described in the informed consent FICT;
- Patients suffering from sensitivity studies heparin sodium;
- Patients with hypersensitivity to search benzyl alcohol;
- Patients with search history of bleeding disorders or disease that a bleeding disorder can worsen or terminate the clinical picture, for example, frames of gastric ulcer;
- Patients with a history of research peptic ulcer;
- Patient with cancer research because of the possibility of impairment of variable coagulation function;
- Patients who are research during pregnancy and postpartum;
- Individuals with a genetic abnormality of the coagulation system;
- Trauma patients;
- Patients on glucocorticoid therapy for at least 1 month;
- Patients using other anticoagulants;
- Patients with a high rate of bleeding;
- Patients undergoing any surgery performed less than 15 days due to the risk of bruising at the site of surgery.
- Patients using drugs that affect hemostasis
- Patients using the following drugs: Salicylates systemic aspirin and other NSAIDs, including ketorolac, Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.
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||LAL Clínica Pesquisa e Desenvolvimento Ltda
History of Changes
|Other Study ID Numbers:
||HEPEUR1009, Version 01
|Study First Received:
||December 16, 2009
||January 27, 2011
||Brazil: National Health Surveillance Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action