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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00914472
First received: June 4, 2009
Last updated: October 26, 2010
Last verified: December 2009

June 4, 2009
October 26, 2010
April 2010
March 2011   (final data collection date for primary outcome measure)
Effectiveness of heparin in thrombi formation. [ Time Frame: 12 consecutive sessions ] [ Designated as safety issue: No ]
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.
Thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00914472 on ClinicalTrials.gov Archive Site
  • Alteration of the pharmacodynamic parameters. [ Time Frame: 12 consecutive sessions. ] [ Designated as safety issue: No ]
    During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.
  • Evaluation of Anti-Xa [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ] [ Designated as safety issue: No ]
  • Evaluation of TTPA [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ] [ Designated as safety issue: No ]
  • Evaluation of Anti-Xa [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Thrombus
  • Biological: heparin sodium - APP
    Heparin 5000 IU / mL
  • Biological: Heparin sodium - Hipolabor
    Heparin 5000 IU / mL
  • Experimental: Test
    Heparin - Hipolabor
    Intervention: Biological: Heparin sodium - Hipolabor
  • Active Comparator: Ative comparator
    Heparin - APP
    Intervention: Biological: heparin sodium - APP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Not Provided
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00914472
HEPHIP0509, Version 01
No
Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP