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Efficacy and Safety of Sodium Heparin in Patients (Cristália)

NCT00894998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2013-02-25

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery

Interventions

BIOLOGICAL

heparin sodium - Cristália

Heparin sodium 5000UI - Cristália

BIOLOGICAL

Heparin sodium APP

Heparin Sodium 5.000 USP - APP

Sponsors & Collaborators

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

  • Alexandre Frederico, Doctor · LAL Clinical Reseach e Development Ltda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-09-30
Completion
2011-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894998 on ClinicalTrials.gov