Overview

This trial is active, not recruiting.

Condition thrombus
Treatments heparin sodium - app, heparin sodium - hipolabor
Phase phase 3
Sponsor L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Start date April 2010
End date March 2011
Trial size 120 participants
Trial identifier NCT00914472, HEPHIP0509, Version 01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Heparin - Hipolabor
heparin sodium - hipolabor
Heparin 5000 IU / mL
(Active Comparator)
Heparin - APP
heparin sodium - app
Heparin 5000 IU / mL

Primary Outcomes

Measure
Effectiveness of heparin in thrombi formation.
time frame: 12 consecutive sessions

Secondary Outcomes

Measure
Alteration of the pharmacodynamic parameters.
time frame: 12 consecutive sessions.
Evaluation of Anti-Xa
time frame: 12 consecutive sessions (4 weeks - 3times/week)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..