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Trial record 47 of 990 for:    Heparin sodium

Safe Use of Heparin Sodium Laboratory Blausiegel Compared to Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure. (Heparin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229072
Recruitment Status : Suspended
First Posted : October 27, 2010
Last Update Posted : October 27, 2010
Information provided by:
Azidus Brasil

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.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Biological: Heparin sodic Biological: heparin liquemine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2008
Estimated Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Heparin Blausiegel
Biological: Heparin sodic
Heparin sodic 150UI/kg

Active Comparator: 2
Biological: heparin liquemine
Heparin sodic 150UI/kg

Primary Outcome Measures :
  1. Safety use of the heparin in patients with renal failure. [ Time Frame: 12 dialysis sessions ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01229072

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Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil

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Responsible Party: Alexandre Frederico, LAL Clinica Identifier: NCT01229072     History of Changes
Other Study ID Numbers: HEPBLA0108
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: October 2008

Keywords provided by Azidus Brasil:

Additional relevant MeSH terms:
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Calcium heparin
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action