NCT01229072

Safe Use of Heparin Sodium in Patients With Chronic Renal Failure.

Clinical Study to Assess the Safety of the Use of the Drug Heparin Sodium Produced by the Laboratory Blausiegel Compared in Parallel to the Product Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure.

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. The end result of these actions is the inhibition of biochemical training and synthesis of certain clotting factors that activators of critical functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct thrombin inhibitor and / or heparinóides to prevent thrombosis. Based on clinical studies, to control the level of plasma heparin in patients with CRF is essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa should be used as a substrate of protection for those patients on hemodialysis.

Conditions

• Chronic Renal Failure

Interventions

Type	Name	Description
BIOLOGICAL	Heparin sodic	Heparin sodic 150UI/kg
BIOLOGICAL	heparin liquemine	Heparin sodic 150UI/kg

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2010-10-27
• Last updated: 2022-11-03

Locations

1 site across 1 country: Brazil