Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.

Last updated: October 26, 2010
Sponsor: Azidus Brasil
Overall Status: Trial Status Unknown

Phase

3

Condition

Thrombosis

Kidney Disease

Kidney Failure

Treatment

N/A

Clinical Study ID

NCT00914472
HEPHIP0509
Version 01
  • Ages > 18
  • All Genders

Study Summary

Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Research that patients agreed to participate and signed the written informed consent;

  2. Patients aged over 18 years, both sexes, regardless of color or social class;

  3. Patients with impaired renal function in chronic hemodialysis schedule of at least 3times a week and giving the use of heparin in the prophylaxis of thrombosis in thesystem.

Exclusion

Exclusion Criteria:

  1. Hypersensitivity to heparin sodium and / or benzyl alcohol;

  2. History of bleeding or disease that the change of blood coagulation could aggravate orterminate the clinical manifestations, such as tables of active peptic or gastriculcer;

  3. Severe liver disease;

  4. Cancer;

  5. Period of gestation;

  6. Genetic abnormality of the coagulation system;

  7. Multiple trauma;

  8. Use of aspirin in high doses (above 200mg per day);

  9. Use of glucocorticoids for at least 1 month;

  10. Use of other anticoagulants;

  11. Submission of a big surgery done less than 15 days;

  12. History of persistent hypertension at the end of dialysis than 150/100 mmHg;

  13. Indicated doses of heparin 20% above or below 150UI/kg.

Study Design

Total Participants: 120
Study Start date:
April 01, 2010
Estimated Completion Date:

Connect with a study center

  • Lal Clinica Pesquisa E Desenvolvimento Ltda

    Valinhos, SP 13270000
    Brazil

    Site Not Available

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