Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
- 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 ]
- 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 ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||February 2012|
|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
No Contacts or Locations Provided