Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure

NCT ID: NCT01034488

Last Updated: 2011-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-02-29

Brief Summary

1. 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.

2. 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.

Conditions

Pharmacodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Heparin sodium - APP

5000UI / mL

Group Type: ACTIVE_COMPARATOR

Suine

Intervention Type: BIOLOGICAL

5000UI /mL

Heparin - Eurofarma

5000 UI/ mL

Group Type: EXPERIMENTAL

Suine

Intervention Type: BIOLOGICAL

5000UI/mL

Interventions

Suine

5000UI /mL

Intervention Type: BIOLOGICAL

Suine

5000UI/mL

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clínica Pesquisa e Desenvolvimento Ltda

Other Identifiers

Version 01

Identifier Type: -

Identifier Source: secondary_id

HEPEUR1009

Identifier Type: -

Identifier Source: org_study_id