Status:
COMPLETED
Safety Evaluation of Use Sodic Enoxaparin
Lead Sponsor:
Azidus Brasil
Conditions:
Kidney Disease
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate safety, not inferiority clinical and pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when compared with Clexane produc...
Detailed Description
Hemodialysis is a filtering and cleaning process of endogenous and exogenous metabolic blood products. The level control of anticoagulants in patients with chronic renal disease is indispensable. Evid...
Eligibility Criteria
Inclusion
- Adults of both sexes, regardless of colour or social class;
- Above 18 years age, with good clinical features, to medical criterion;
- Patients who agreed to participate and signed the Informed Consent;
- Patients with Chronic Kidney Disease in hemodialysis treatment (3 times per week);
- Patients with clearance of creatinine \<30ml/min;
- Patients with details of anticoagulants during hemodialysis.
Exclusion
- Not agree to the terms described in Informed Consent;
- Volunteers bearers of the sensitivity enoxaparin sodium;
- Volunteers Patients with hypersensitivity to benzyl alcohol;
- Volunteers with a history of bleeding or disease that change of blood clotting could aggravate or terminate the clinical picture, such as tables of gastric ulcer;
- Volunteers with a history of peptic ulcer;
- Patients with body mass index greater than 30;
- Patients with cancer because of the possibility of compromising the function of the variable clotting;
- Patients in a period of post-pregnancy or childbirth;
- Patients with genetic abnormality of the system of coagulation;
- Polytraumatized patients;
- Patients in use of glucocorticoids for at least 1 month;
- Patients in use of other anticoagulants;
- Patients with high rate of bleeding;
- Patients undergo any surgery performed less than 15 days due to the risk of the formation of bruising at the site of surgery.
- Hypertension above 140/90 mmHg
- Patients in use of medicines could affect the hemostasis
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00673426
Start Date
January 1 2008
End Date
April 1 2008
Last Update
May 7 2008
Active Locations (1)
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1
Clinica TOP Nefrologia e Diálise
Americana, Brazil