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

Sponsor

Azidus Brasil (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00914472

Collaborator

(none)

120

Enrollment

Location

Arms

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Effectiveness of heparin in thrombi formation. [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

Alteration of the pharmacodynamic parameters. [12 consecutive sessions.]
During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.
Evaluation of Anti-Xa [12 consecutive sessions (4 weeks - 3times/week)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Research that patients agreed to participate and signed the written informed consent;
Patients aged over 18 years, both sexes, regardless of color or social class;
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:

Hypersensitivity to heparin sodium and / or benzyl alcohol;
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;
Severe liver disease;
Cancer;
Period of gestation;
Genetic abnormality of the coagulation system;
Multiple trauma;
Use of aspirin in high doses (above 200mg per day);
Use of glucocorticoids for at least 1 month;
Use of other anticoagulants;
Submission of a big surgery done less than 15 days;
History of persistent hypertension at the end of dialysis than 150/100 mmHg;
Indicated doses of heparin 20% above or below 150UI/kg.