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

Primary Purpose

Chronic Renal Failure

Status
Suspended
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Heparin sodic
heparin liquemine
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring Safety, Non-inferiority

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lal Clinica Pesquisa E Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Heparin Blausiegel

Liquemine

Outcomes

Primary Outcome Measures

Safety use of the heparin in patients with renal failure.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2008
Last Updated
November 1, 2022
Sponsor
Azidus Brasil
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1. Study Identification

Unique Protocol Identification Number
NCT01229072
Brief Title
Safe Use of Heparin Sodium in Patients With Chronic Renal Failure.
Acronym
Heparin
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Study Start Date
July 2008 (Actual)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azidus Brasil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Safety, Non-inferiority

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Heparin Blausiegel
Arm Title
2
Arm Type
Active Comparator
Arm Description
Liquemine
Intervention Type
Biological
Intervention Name(s)
Heparin sodic
Intervention Description
Heparin sodic 150UI/kg
Intervention Type
Biological
Intervention Name(s)
heparin liquemine
Intervention Description
Heparin sodic 150UI/kg
Primary Outcome Measure Information:
Title
Safety use of the heparin in patients with renal failure.
Time Frame
12 dialysis sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lal Clinica Pesquisa E Desenvolvimento Ltda
City
Valinhos
State/Province
Sao Paulo
ZIP/Postal Code
13270000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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