Erythropoietin and Pediatric Cardiac Surgery (EPO)
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Purpose
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 5 years, requiring heart bypass surgery for congenital heart defects.
| Condition | Intervention |
|---|---|
|
Congenital Heart Defect |
Drug: cyanotic erythropoietin Drug: cyanotic placebo Drug: acyanotic erythropoietin Drug: acyanotic placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Erythropoietin and Pediatric Cardiac Surgery |
- Biochemical markers of heart damage [ Time Frame: 4 postoperative time points ] [ Designated as safety issue: No ]
- Biochemical markers of neuron damage [ Time Frame: 4 postoperative time points ] [ Designated as safety issue: No ]
- Echocardiographic assessment of heart function [ Time Frame: 24 hours postop ] [ Designated as safety issue: No ]
- Inotropic support [ Time Frame: 24 and 48 hours post operative ] [ Designated as safety issue: No ]
- Length of hospitalization [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
cyanotic placebo
|
Drug: cyanotic placebo
Single dose IV push
|
|
Experimental: 2
cyanotic erythropoietin
|
Drug: cyanotic erythropoietin
Single dose IV push
|
|
Placebo Comparator: 3
acyanotic placebo
|
Drug: acyanotic placebo
Single dose IV push
|
|
Experimental: 4
acyanotic erythropoietin
|
Drug: acyanotic erythropoietin
Single dose IV push
|
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 5 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.
Eligibility| Ages Eligible for Study: | 6 Weeks to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 6 weeks to 5 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 -
Contacts and Locations| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Steve Zangwill, MD | Children's Hospital and Health System Foundation, Wisconsin |
| Principal Investigator: | John Baker, PhD | Medical College of Wisconsin |
More Information
Publications:
| Responsible Party: | Steven Zangwill, Associate Professor, Pediatrics, Cardiology, Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00451698 History of Changes |
| Other Study ID Numbers: | CHW 04/161 |
| Study First Received: | March 22, 2007 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medical College of Wisconsin:
|
Erythropoietin Congenital heart surgery |
Additional relevant MeSH terms:
|
Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013