Erythropoietin and Pediatric Cardiac Surgery (EPO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00451698|
Recruitment Status : Terminated (Inadequate patient enrollment)
First Posted : March 23, 2007
Results First Posted : July 16, 2013
Last Update Posted : July 31, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Defect||Drug: acyanotic erythropoietin Drug: acyanotic placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Erythropoietin and Pediatric Cardiac Surgery|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Placebo Comparator: 3
Drug: acyanotic placebo
Single dose IV push
Drug: acyanotic erythropoietin
Single dose IV push
- Biochemical Markers of Heart Damage [ Time Frame: 4 postoperative time points ]Troponin I levels (ng/ml) measured at 4 time points
- Biochemical Markers of Neuron Damage [ Time Frame: 4 postoperative time points ]
- Echocardiographic Assessment of Heart Function [ Time Frame: 24 hours postop ]
- Inotropic Support [ Time Frame: 24 and 48 hours post operative ]
- Length of Hospitalization [ Time Frame: at hospital discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451698
|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|