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

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Drug: Heptar; Drug: Liquaemin

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;

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium heparin (Heptar); Sodium heparin (Heptar®) produced by Eurofarma Laboratory,	Drug: Heptar; The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.; Other Names: Sodium heparin
Active Comparator: Liquemine®; Roche Lab's Liquemine®	Drug: Liquaemin; The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: EF101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No