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Erythropoietin and Pediatric Cardiac Surgery

NCT00451698 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-11-08

Study results available
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Summary

Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury.

This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

Conditions

  • Congenital Heart Defect

Interventions

DRUG

acyanotic erythropoietin

Single dose IV push

DRUG

acyanotic placebo

Single dose IV push

Sponsors & Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Steve Zangwill, MD · Children's Hospital and Health System Foundation, Wisconsin

  • John Baker, PhD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

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 NCT00451698 on ClinicalTrials.gov