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

Azidus

Status and phase

Unknown

Phase 3

Conditions

Thrombus

Treatments

Biological: Heparin sodium - Hipolabor

Biological: heparin sodium - APP

Study type

Interventional

Funder types

Industry

Identifiers

NCT00914472

Version 01

HEPHIP0509

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.