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Trial record 43 of 990 for:    Heparin sodium

Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure. (HEPHIP0509)

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: NCT00914472
Recruitment Status : Unknown
Verified December 2009 by Azidus Brasil.
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2009
Last Update Posted : October 27, 2010
Information provided by:
Azidus Brasil

Brief 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

Condition or disease Intervention/treatment Phase
Thrombus Biological: heparin sodium - APP Biological: Heparin sodium - Hipolabor Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.
Study Start Date : April 2010
Estimated Primary Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test
Heparin - Hipolabor
Biological: Heparin sodium - Hipolabor
Heparin 5000 IU / mL

Active Comparator: Ative comparator
Heparin - APP
Biological: heparin sodium - APP
Heparin 5000 IU / mL

Primary Outcome Measures :
  1. Effectiveness of heparin in thrombi formation. [ Time Frame: 12 consecutive sessions ]
    During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin.

Secondary Outcome Measures :
  1. Alteration of the pharmacodynamic parameters. [ Time Frame: 12 consecutive sessions. ]
    During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.

  2. Evaluation of Anti-Xa [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ]

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:

  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 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system.

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 or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
  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.

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): NCT00914472

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

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Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda Identifier: NCT00914472     History of Changes
Other Study ID Numbers: HEPHIP0509
Version 01
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: December 2009

Keywords provided by Azidus Brasil:
Preventing the thrombi formation

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