Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
- Phase 3
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Heparin sodium - APP
5000UI / mL
|
5000UI /mL
5000UI/mL
|
|
Expérimental: Heparin - Eurofarma
5000 UI/ mL
|
5000UI /mL
5000UI/mL
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Effect (activity) of heparin observed for markers for aPTT and anti-Xa.
Délai: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.
|
12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Effectiveness in maintaining the absence clotting during hemodialysis.
Délai: 12 consecutive sessions
|
12 consecutive sessions
|
|
Safety in use of the drug by monitoring events complicating the use of heparin
Délai: 12 consecutive sessions
|
12 consecutive sessions
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HEPEUR1009
- Version 01
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