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

NCT ID: NCT00914472

Last Updated: 2010-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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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

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Conditions

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Thrombus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Test

Heparin - Hipolabor

Group Type EXPERIMENTAL

Heparin sodium - Hipolabor

Intervention Type BIOLOGICAL

Heparin 5000 IU / mL

Ative comparator

Heparin - APP

Group Type ACTIVE_COMPARATOR

heparin sodium - APP

Intervention Type BIOLOGICAL

Heparin 5000 IU / mL

Interventions

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heparin sodium - APP

Heparin 5000 IU / mL

Intervention Type BIOLOGICAL

Heparin sodium - Hipolabor

Heparin 5000 IU / mL

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

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LAL Clinica Pesquisa e Desenvolvimento Ltda

Locations

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Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Version 01

Identifier Type: -

Identifier Source: secondary_id

HEPHIP0509

Identifier Type: -

Identifier Source: org_study_id