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

Hemodialysis Complication Clinical Trial

— HEPIRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148377
• Other study ID #: EF101
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2007
• Est. completion date: December 1, 2008

Study information

• Verified date: January 2020
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 1, 2008
• Est. primary completion date: December 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults of both sexes, regardless of color or social class;

• Age over 18 years, with good clinical characteristics at medical discretion;

• Research patients who agree to participate in the study and sign the consent form free and informed;

• Chronic renal failure patients on dialysis regimen (3 times a week).

• Chronic Kidney Failure with indication for anticoagulant during dialysis

Exclusion Criteria:

• Not agreeing with the terms described in the informed consent;

• Research patients with sensitivity to sadistic heparin;

• Research patients with hypersensitivity to benzyl alcohol;

• Research patients with a history of bleeding or disease that change in coagulation may worsen or terminate the clinical picture, such as ulcer gastric;

• Research patients with a history of peptic ulcer.

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

Drug:
• Liquaemin
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
• Heptar
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss due to system coagulation during 4 weeks of hemodialysis	Evaluation of the change of the useful volume of the system below	4 weeks
Primary	Loss of venous capillary by clot formation during 4 weeks of hemodialysis	Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions	4 weeks
Primary	Change of the useful volume of the system in the dialyzer (priming of dialyzer)	Occurrence of events related to the reduction of the useful volume of the system below 80% by thrombus formation in the dialyzer in the 12 hemodialysis sessions	4 weeks