NCT05148377

UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured by by Roche Laboratory in patients with renal failure undergoing hemodialysis treatment

Detailed description

Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparino tested. The study was conducted with the participation of 110 chronic renal failure patients of both sexes. over 18 years old who are undergoing hemodialysis treatment 3 times a week and who fit inclusion and exclusion criteria. The investigational products properly patients were administered during 12 consecutive treatment sessions. Hemodialysis at a dose of 150 IU per kg of weight. The study patients were followed clinically and on a laboratory basis in all hemodialysis sessions according to criteria established by the protocol for verifying the safety in use of the product in study. The evaluation parameters are: * Pharmacodynamic effect curve (activity) of heparin verified by dosing of TYPE and anti-Xa markers. * Effectiveness in maintaining blood coagulation during hemodialysis. * Blood loss by coagulation of the system; * Blood clotting and venous capillary loss; * Trunk of the capillary diolysor in the 12 follow-up sessions. * Safety in drug use through event monitoring complicating the use of heparin as: * Increased hematocrit of the patient; * Thrombocytopenia; * Bruise; * Fever; * Reactions to allergic agents;

Conditions

• Hemodialysis Complication

Interventions

Type	Name	Description
DRUG	Liquaemin	The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
DRUG	Heptar	The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2021-12-08
• Last updated: 2021-12-27