Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451698
Status:
TERMINATED
Last Update Posted:
2018-11-08
First Post:
2007-03-22
Brief Title:
Erythropoietin and Pediatric Cardiac Surgery
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Erythropoietin and Pediatric Cardiac Surgery
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPO
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
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
Erythropoietins 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
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
Erythropoietins 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None