Erythropoietin and Pediatric Cardiac Surgery

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborators: Children's Hospital and Health System Foundation, Wisconsin; National Center for Research Resources (NCRR)
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Age 6 weeks to 18 years

• Requiring open heart surgery for congenital heart defect -Parents able to speak English and document informed consent -

Exclusion Criteria:

• 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 -