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

NCT ID: NCT05148377

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-01

Study Completion Date

2008-12-01

Brief Summary

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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

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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

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Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The pharmaceutical presentation of the medication to be studied is: solution for injection packaged in 5ml vial and 0.25ml ampoule. All doses have been prepared prior to administration to patients by the LAL Clinic Pharmacy which knows the randomization of the study. It is preparation consisted of preparing the dose of each patient previously calculated based on the weight of each patient and the pharmaceutical presentation of the product randomized into standard 3 ml syringes.

Study Groups

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Sodium heparin (Heptar)

Sodium heparin (Heptar®) produced by Eurofarma Laboratory,

Group Type EXPERIMENTAL

Heptar

Intervention Type DRUG

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

Liquemine®

Roche Lab's Liquemine®

Group Type ACTIVE_COMPARATOR

Liquaemin

Intervention Type DRUG

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

Interventions

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Liquaemin

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

Intervention Type DRUG

Heptar

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

Intervention Type DRUG

Other Intervention Names

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Sodium heparin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EF101

Identifier Type: -

Identifier Source: org_study_id