Safe Use of Heparin Sodium in Patients With Chronic Renal Failure.

NCT ID: NCT01229072

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2008-07-31

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.

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Heparin Blausiegel

Group Type: EXPERIMENTAL

Heparin sodic

Intervention Type: BIOLOGICAL

Heparin sodic 150UI/kg

2

Liquemine

Group Type: ACTIVE_COMPARATOR

heparin liquemine

Intervention Type: BIOLOGICAL

Heparin sodic 150UI/kg

Interventions

Heparin sodic

Heparin sodic 150UI/kg

Intervention Type: BIOLOGICAL

heparin liquemine

Heparin sodic 150UI/kg

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Azidus Brasil

Principal Investigator Dr. Alexandre Frederico

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

HEPBLA0108

Identifier Type: -

Identifier Source: org_study_id