Clinical Trials Directory

Trials / Completed

CompletedNCT00894985

Efficacy and Safety of Sodium Heparin

Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
104 (actual)
Sponsor
Azidus Brasil · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The objective of this study is to verify, through a randomized, open, 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

Interventions

TypeNameDescription
BIOLOGICALheparin sodium - blausiegelheparin sodium 5.000UI
BIOLOGICALheparin sodium - APPheparin sodium 5.000 USP - APP

Timeline

Start date
2009-06-01
Primary completion
2009-09-01
Completion
2011-12-01
First posted
2009-05-07
Last updated
2013-02-25

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00894985. Inclusion in this directory is not an endorsement.