Safe Use of Heparin Sodium in Patients With Chronic Renal Failure. (Heparin)

November 1, 2022 updated by: Azidus Brasil

Clinical Study to Assess the Safety of the Use of the Drug Heparin Sodium Produced by the Laboratory Blausiegel Compared in Parallel to the Product Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure.

The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. The end result of these actions is the inhibition of biochemical training and synthesis of certain clotting factors that activators of critical functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct thrombin inhibitor and / or heparinóides to prevent thrombosis.

Based on clinical studies, to control the level of plasma heparin in patients with CRF is essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa should be used as a substrate of protection for those patients on hemodialysis.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Valinhos, Sao Paulo, Brazil, 13270000
        • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 above 18 years;
  • Patients who agree to participate in the study and signed the free and informed consent (attached);
  • Insufficient patients in chronic renal dialysis scheme (3 times per week);
  • Low Chronic Renal indication of anticoagulant during dialysis.

Exclusion Criteria:

  • Not agree to the terms described in informed consent;
  • Patients with sensitivity to heparin sodium;
  • Volunteer search with hypersensitivity to benzyl alcohol;
  • Patients with a history of bleeding or change in blood clotting that can aggravate or terminate the clinical picture, such as tables of gastric ulcer;
  • Patients with a history of peptic ulcer;
  • Patients with cancer of any etiology, because of the possibility of compromising the function of the variable coagulation;
  • Patients in a period of pregnancy and postpartum;
  • Individuals with genetic abnormality of clotting system;
  • Patients polytraumatized;
  • Patients in use of glucocorticoids for at least 1 month;
  • Patients in use of other anticoagulants;
  • Patients with high rate of bleeding;
  • Patients undergo any surgery performed less than 15 days because of the risk of the formation of hematomas at the site of surgery;
  • Patients in use of drugs that affect the hemostasis;
  • In addition to these, clinical characteristics that the medical criteria, can interfere with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Heparin Blausiegel
Biological: Heparin sodic
Heparin sodic 150UI/kg
Active Comparator: 2
Liquemine
Biological: heparin liquemine
Heparin sodic 150UI/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety use of the heparin in patients with renal failure.
Time Frame: 12 dialysis sessions
12 dialysis sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion

July 1, 2008

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 26, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPBLA0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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