Erythropoietin and Pediatric Cardiac Surgery

Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can
cause damage to those organs. A medicine already used in humans, erythropoietin, may protect
the heart and brain of children born with heart defects during their surgical repair. In a
rabbit model, erythropoietin did protect the hearts. 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.

For this randomized control trial, 120 children, age 6 weeks to 18 years, requiring heart
bypass surgery for congenital heart defects, will be divided into four groups. Two groups
will be children whose usual blood oxygen level is low because of their heart defect; the
other two will be children with normal blood oxygen levels. Each child will be randomized to
receive either erythropoietin or placebo 15 minutes prior to stopping the heart during their
surgery.

Erythropoietin's protective function will be measured after surgery by: (1) amount of
medication required to support heart function, (2) how well the heart pumps blood as seen by
echocardiogram, (3) levels of chemicals produced by the body when heart or brain tissue
injury occurs, (4) urine output and oxygen levels (5) time on ventilator support (6) ICU stay
and (7) hospital stay. Heart tissue will be collected during surgery to determine how
erythropoietin protects heart cells.

Statistical tests including ANOVA will test for similarities and differences among the groups
on the measures of protection from injury.

Note - the study design was edited after the FDA released a warning about the use of
erythropoietin. Only acyanotic patients were recruited therefore only 2 study groups are
included.

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 -