Status:
UNKNOWN
Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
Lead Sponsor:
Azidus Brasil
Conditions:
Thrombus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hemodialysi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00914472
Start Date
April 1 2010
Last Update
October 27 2010
Active Locations (1)
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1
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270000