Status:
COMPLETED
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
Lead Sponsor:
Azidus Brasil
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and second...
Eligibility Criteria
Inclusion
- Adults of both sexes, regardless of color or social class
- Age over 18 years with a good clinical medical criteria
- Patients who agreed to participate and signed the Informed Consent
- Insufficient patients in chronic renal dialysis schedule (3 times per week)
- Patients with creatinine clearance \<30ml/min
- Patients with indication for anticoagulation during hemodialysis
Exclusion
- Patients with sensitivity to heparin sodium;
- Patients with hypersensitivity to benzyl alcohol
- Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer
- Patients with a history of peptic ulcer
- Patients with body mass index greater than 30
- Cancer patients because of the possibility of compromising the function of the variable coagulation
- Patients in period of pregnancy or after delivery
- Patients with genetic abnormality of the clotting system
- Polytraumatized patients
- Patients using glucocorticoids for at least 1 month
- Patients using other anticoagulants
- Patients with high rate of bleeding
- Patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery
- Hypertension above 140/90 mmHg
- Patients using medications that could affect hemostasis
- Patients using the following medicines: hormonal anti not including Ketorolac; Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00828776
Start Date
September 1 2007
End Date
March 1 2008
Last Update
January 26 2009
Active Locations (1)
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1
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270000