Erythropoietin and Pediatric Cardiac Surgery

Congenital Heart Defect Clinical Trial

— EPO  

Official title:

Erythropoietin and Pediatric Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00451698
• Other study ID #: CHW 04/161
• Status: Terminated
• Phase: N/A
• Start date: October 2007
• Est. completion date: December 2011

Study information

• Verified date: October 2018
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Weeks to 18 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital

Intervention

Drug:
• acyanotic erythropoietin
Single dose IV push
• acyanotic placebo
Single dose IV push

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin, National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shi Y, Rafiee P, Su J, Pritchard KA Jr, Tweddell JS, Baker JE. Acute cardioprotective effects of erythropoietin in infant rabbits are mediated by activation of protein kinases and potassium channels. Basic Res Cardiol. 2004 May;99(3):173-82. Epub 2004 Jan 29. Erratum in: Basic Res Cardiol. 2004 May;99(3):239. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Markers of Heart Damage	Troponin I levels (ng/ml) measured at 4 time points	4 postoperative time points up to 48 hours
Primary	Biochemical Markers of Neuron Damage		4 postoperative time points
Primary	Echocardiographic Assessment of Heart Function		24 hours postop
Secondary	Inotropic Support		24 and 48 hours post operative
Secondary	Length of Hospitalization		At hospital discharge, up to 30 days