Efficacy and Safety of Sodium Heparin (Eurofarma) | NCT00894829

Studies
Efficacy and Safety of Sodium Heparin (Eurofarma)

NCT00894829

Sponsor

Azidus Brasil

Status

Completed

Last Update Posted

Feb 25, 2013Estimated

Enrollment

104Actual

Phase

Phase 3

Conditions

Cardiac Surgery

Interventions

heparin sodium - Eurofarma
heparin sodium - APP

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
Heparin Eurofarma (Version 8)

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

May 5, 2009

First Submission Date that Met QC Criteria

May 6, 2009

First Posted Date

May 7, 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

Feb 22, 2013

Last Update Posted Date

Feb 25, 2013Estimated

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

The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.

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

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Heparin sodium - Eurofarma	Biological: heparin sodium - Eurofarma
2	Active Comparator	Heparin APP	Biological: heparin sodium - APP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heparin sodium - Eurofarma	Biological	Heparin sodium 5.000 UI - Eurofarma	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of TTPA, Anti-Xa and ACT		Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Comparison of bleeding		Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative

Secondary Outcomes

Measure	Description	Time Frame
Adverse reactions		Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who agree with all aspects of the study and sign the FICT;
Patients of both sexes;
Patients aged above 18 years;
Patients with cardiac surgery and requiring movement; AND
Extracorporeal.

Exclusion Criteria:

Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb <11.0 g / dL,
Platelets < 150,000 mm3);
Patients with disorders of hemostasis (INR> 1.40) (rTTPA> 1.40);
Patients with renal dysfunction (creatinine> 1.50);
Patients with deep hyperthermia;
Liver disease (AST and ALT> 2 times that of the reference value);
Patients with a history of allergy to heparin or protamine;
Patients with history of heparin-induced thrombocytopenia;
Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
Reoperations;
Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
Use of acetylsalicylic acid is less than 5 days;
Use of low molecular weight heparin for less than 24 hours; OR
Use of non-fractioned heparin for less than 12 hours.

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