Erythropoietin and Pediatric Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
Erythropoietin and Pediatric Cardiac Surgery

Conditions
-----------------
Congenital Heart Defect

Intervention / Treatment
-----------------
* Drug: acyanotic erythropoietin
* Drug: acyanotic placebo


Participation Criteria
=================
Eligibility 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 -

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3<br>acyanotic placebo | Drug: acyanotic placebo<br>* Single dose IV push<br>|
| Experimental: 4<br>acyanotic erythropoietin | Drug: acyanotic erythropoietin<br>* Single dose IV push<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Markers of Heart Damage | Troponin I levels (ng/ml) measured at 4 time points | 4 postoperative time points up to 48 hours | 
| Biochemical Markers of Neuron Damage |  | 4 postoperative time points | 
| Echocardiographic Assessment of Heart Function |  | 24 hours postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inotropic Support |  | 24 and 48 hours post operative | 
| Length of Hospitalization |  | At hospital discharge, up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erythropoietin, Congenital heart surgery