Back to resultsComparison of Two Heparin Formulations in Patients With Chronic Renal Failure. (HEPHIP0509)
Primary Purpose
Thrombus
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
heparin sodium - APP
Heparin sodium - Hipolabor
Sponsored by
About this trial
This is an interventional prevention trial for Thrombus focused on measuring Preventing the thrombi formation
Eligibility Criteria
Inclusion Criteria:
- Research that patients agreed to participate and signed the written informed consent;
- Patients aged over 18 years, both sexes, regardless of color or social class;
- 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:
- Hypersensitivity to heparin sodium and / or benzyl alcohol;
- 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;
- Severe liver disease;
- Cancer;
- Period of gestation;
- Genetic abnormality of the coagulation system;
- Multiple trauma;
- Use of aspirin in high doses (above 200mg per day);
- Use of glucocorticoids for at least 1 month;
- Use of other anticoagulants;
- Submission of a big surgery done less than 15 days;
- History of persistent hypertension at the end of dialysis than 150/100 mmHg;
- Indicated doses of heparin 20% above or below 150UI/kg.
Sites / Locations
- Lal Clinica Pesquisa E Desenvolvimento Ltda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test
Ative comparator
Arm Description
Heparin - Hipolabor
Heparin - APP
Outcomes
Primary Outcome Measures
Effectiveness of heparin in thrombi formation.
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
Alteration of the pharmacodynamic parameters.
During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.
Evaluation of Anti-Xa
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00914472
Brief Title
Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
Acronym
HEPHIP0509
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Azidus Brasil
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombus
Keywords
Preventing the thrombi formation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Heparin - Hipolabor
Arm Title
Ative comparator
Arm Type
Active Comparator
Arm Description
Heparin - APP
Intervention Type
Biological
Intervention Name(s)
heparin sodium - APP
Intervention Description
Heparin 5000 IU / mL
Intervention Type
Biological
Intervention Name(s)
Heparin sodium - Hipolabor
Intervention Description
Heparin 5000 IU / mL
Primary Outcome Measure Information:
Title
Effectiveness of heparin in thrombi formation.
Description
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.
Time Frame
12 consecutive sessions
Secondary Outcome Measure Information:
Title
Alteration of the pharmacodynamic parameters.
Description
During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.
Time Frame
12 consecutive sessions.
Title
Evaluation of Anti-Xa
Time Frame
12 consecutive sessions (4 weeks - 3times/week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Research that patients agreed to participate and signed the written informed consent;
Patients aged over 18 years, both sexes, regardless of color or social class;
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:
Hypersensitivity to heparin sodium and / or benzyl alcohol;
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;
Severe liver disease;
Cancer;
Period of gestation;
Genetic abnormality of the coagulation system;
Multiple trauma;
Use of aspirin in high doses (above 200mg per day);
Use of glucocorticoids for at least 1 month;
Use of other anticoagulants;
Submission of a big surgery done less than 15 days;
History of persistent hypertension at the end of dialysis than 150/100 mmHg;
Indicated doses of heparin 20% above or below 150UI/kg.
Facility Information:
Facility Name
Lal Clinica Pesquisa E Desenvolvimento Ltda
City
Valinhos
State/Province
SP
ZIP/Postal Code
13270000
Country
Brazil
12. IPD Sharing Statement
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Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
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