Erythropoietin and Pediatric Cardiac Surgery

Stopped early · Not applicable · Has a placebo group

Conditions studied: Congenital Heart Defect

In brief

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.

Key facts

Study ID

NCT00451698

Run by

Medical College of Wisconsin

People needed

9

Starts

2007-10-01

Expected to finish

2011-12-01

Last updated by the study team

2018-11-08

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6 weeks to 18 years
• Requiring open heart surgery for congenital heart defect -Parents able to speak English and document informed consent -

You may not qualify if…

• Received erythropoietin within past 30 days
• Previous adverse reaction to erythropoietin or to albumin
• History of neurological disorder -Laboratory evidence of kidney or liver dysfunction -

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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