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Efficacy and Safety of Sodium Heparin in Patients Submitted to Heart Surgery Using Bypass

NCT00905216 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2011-01-28

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 that require the aid of cardiopulmonary bypass. The effectiveness will be determined through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation trichloroacetic acid (TCA), alpha-tocopherol transfer protein (TTPA), Anti-Xa, heparin bioavailability and excessive loss of blood (bleeding) at the end of the surgery.

Conditions

  • Cardiac Surgery

Interventions

DRUG

heparin sodium - Bergamo

5.000 UI/mL

DRUG

heparin sodium - APP

5.000 USP

Sponsors & Collaborators

  • Azidus Brasil

    lead INDUSTRY

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 NCT00905216 on ClinicalTrials.gov