Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thrombus
Intervention: heparin sodium - APP (Biological); Heparin sodium - Hipolabor (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Effectiveness of heparin in thrombi formation.
Secondary outcome: Alteration of the pharmacodynamic parameters.Evaluation of Anti-Xa
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Lal Clinica Pesquisa E Desenvolvimento Ltda, Valinhos, SP 13270000, Brazil
Additional Information
Starting date: April 2010
Last updated: October 26, 2010
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