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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 3
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Heparin sodium - APP
5000UI / mL
|
5000UI /mL
5000UI/mL
|
|
Experimental: Heparin - Eurofarma
5000 UI/ mL
|
5000UI /mL
5000UI/mL
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Effect (activity) of heparin observed for markers for aPTT and anti-Xa.
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Effectiveness in maintaining the absence clotting during hemodialysis.
Periodo de tiempo: 12 consecutive sessions
|
12 consecutive sessions
|
|
Safety in use of the drug by monitoring events complicating the use of heparin
Periodo de tiempo: 12 consecutive sessions
|
12 consecutive sessions
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HEPEUR1009
- Version 01
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