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OpenTrials
Completed

NCT Number: NCT05148377

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liquaemin

Drug

The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.

Heptar

Drug

The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.

Other names: Sodium heparin

Primary outcomes

  1. Blood loss due to system coagulation during 4 weeks of hemodialysis

    Time frame: 4 weeks

    Evaluation of the change of the useful volume of the system below

  2. Loss of venous capillary by clot formation during 4 weeks of hemodialysis

    Time frame: 4 weeks

    Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions

  3. Change of the useful volume of the system in the dialyzer (priming of dialyzer)

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

Eurofarma Laboratorios S.A.

Industry

Registry information

Acronym: HEPIRC

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 8, 2021
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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