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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01229072
First received: October 1, 2008
Last updated: October 26, 2010
Last verified: October 2008
  Purpose

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 Intervention Phase
Chronic Renal Failure
Biological: Heparin sodic
Biological: heparin liquemine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Safety use of the heparin in patients with renal failure. [ Time Frame: 12 dialysis sessions ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Heparin Blausiegel
Biological: Heparin sodic
Heparin sodic 150UI/kg
Active Comparator: 2
Liquemine
Biological: heparin liquemine
Heparin sodic 150UI/kg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229072

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT01229072     History of Changes
Other Study ID Numbers: HEPBLA0108
Study First Received: October 1, 2008
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Safety
Non-inferiority

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014