Safe Use of Heparin Sodium Laboratory Blausiegel Compared to Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure.

Sponsor

Azidus Brasil (Industry)

Overall Status

Suspended

CT.gov ID

NCT01229072

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. The end result of these actions is the inhibition of biochemical training and synthesis of certain clotting factors that activators of critical functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct thrombin inhibitor and / or heparinóides to prevent thrombosis.

Based on clinical studies, to control the level of plasma heparin in patients with CRF is essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa should be used as a substrate of protection for those patients on hemodialysis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Failure	Biological: Heparin sodic Biological: heparin liquemine	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Clinical Study to Assess the Safety of the Use of the Drug Heparin Sodium Produced by the Laboratory Blausiegel Compared in Parallel to the Product Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure.

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Heparin Blausiegel	Biological: Heparin sodic Heparin sodic 150UI/kg
Active Comparator: 2 Liquemine	Biological: heparin liquemine Heparin sodic 150UI/kg

Arm

Intervention/Treatment

Experimental: 1

Heparin Blausiegel

Biological: Heparin sodic

Heparin sodic 150UI/kg

Active Comparator: 2

Liquemine

Biological: heparin liquemine

Heparin sodic 150UI/kg

Outcome Measures

Primary Outcome Measures

Safety use of the heparin in patients with renal failure. [12 dialysis sessions]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults of both sexes, regardless of color or social class;
Age above 18 years;
Patients who agree to participate in the study and signed the free and informed consent (attached);
Insufficient patients in chronic renal dialysis scheme (3 times per week);
Low Chronic Renal indication of anticoagulant during dialysis.

Exclusion Criteria:

Not agree to the terms described in informed consent;
Patients with sensitivity to heparin sodium;
Volunteer search with hypersensitivity to benzyl alcohol;
Patients with a history of bleeding or change in blood clotting that can aggravate or terminate the clinical picture, such as tables of gastric ulcer;
Patients with a history of peptic ulcer;
Patients with cancer of any etiology, because of the possibility of compromising the function of the variable coagulation;
Patients in a period of pregnancy and postpartum;
Individuals with genetic abnormality of clotting system;
Patients polytraumatized;
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 because of the risk of the formation of hematomas at the site of surgery;
Patients in use of drugs that affect the hemostasis;
In addition to these, clinical characteristics that the medical criteria, can interfere with the study.