Comparison of Two Heparin Formulations in Patients With C... | NCT00914472

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

NCT00914472

Sponsor

Azidus Brasil

Status

Unknown status

Last Update Posted

Oct 27, 2010Estimated

Enrollment

120Estimated

Phase

Phase 3

Conditions

Thrombus

Interventions

heparin sodium - APP
Heparin sodium - Hipolabor

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Version 01

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Mar 2011Estimated

Completion Date

Not provided

First Submitted Date

Jun 4, 2009

First Submission Date that Met QC Criteria

Jun 4, 2009

First Posted Date

Jun 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2010

Last Update Posted Date

Oct 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental	Heparin - Hipolabor	Biological: Heparin sodium - Hipolabor
Ative comparator	Active Comparator	Heparin - APP	Biological: heparin sodium - APP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heparin sodium - APP	Biological	Heparin 5000 IU / mL	Ative comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 consecutive sessions

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases