Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.

Phase 3

• Conditions: Thrombus
• Interventions: Biological: Heparin sodium - Hipolabor; Biological: heparin sodium - APP

• Registration Number: NCT00914472
• Lead Sponsor: Azidus Brasil

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 hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-05
• Status Verified: 2009-12
• Study Start: 2010-04
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27
• Primary Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Research that patients agreed to participate and signed the written informed consent;
2. Patients aged over 18 years, both sexes, regardless of color or social class;
3. 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 Criteria

1. Hypersensitivity to heparin sodium and / or benzyl alcohol;
2. 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;
3. Severe liver disease;
4. Cancer;
5. Period of gestation;
6. Genetic abnormality of the coagulation system;
7. Multiple trauma;
8. Use of aspirin in high doses (above 200mg per day);
9. Use of glucocorticoids for at least 1 month;
10. Use of other anticoagulants;
11. Submission of a big surgery done less than 15 days;
12. History of persistent hypertension at the end of dialysis than 150/100 mmHg;
13. Indicated doses of heparin 20% above or below 150UI/kg.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Heparin sodium - Hipolabor	Heparin - Hipolabor
Ative comparator	heparin sodium - APP	Heparin - APP

Primary Outcome Measures

Name	Time	Method
Effectiveness of heparin in thrombi formation.	12 consecutive sessions	During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Anti-Xa	12 consecutive sessions (4 weeks - 3times/week)
Alteration of the pharmacodynamic parameters.	12 consecutive sessions.	During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.

Trial Locations

Locations (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil