Erythropoietin and Pediatric Cardiac Surgery

Not Applicable

Terminated

• Conditions: Congenital Heart Defect
• Interventions: Drug: acyanotic placebo; Drug: acyanotic erythropoietin

• Registration Number: NCT00451698
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-03-22
• Study First Submitted QC: 2007-03-22
• Study First Posted: 2007-03-23
• Study Start: 2007-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-03-21
• Results First Submitted QC: 2013-06-11
• Results First Posted: 2013-07-16
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 -

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	acyanotic placebo	acyanotic placebo
4	acyanotic erythropoietin	acyanotic erythropoietin

Primary Outcome Measures

Name	Time	Method
Biochemical Markers of Heart Damage	4 postoperative time points up to 48 hours	Troponin I levels (ng/ml) measured at 4 time points
Biochemical Markers of Neuron Damage	4 postoperative time points
Echocardiographic Assessment of Heart Function	24 hours postop

Secondary Outcome Measures

Name	Time	Method
Inotropic Support	24 and 48 hours post operative
Length of Hospitalization	At hospital discharge, up to 30 days

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States