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Inadequate patient enrollment
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| Name | Class |
|---|---|
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 | Placebo Comparator | acyanotic placebo |
|
| 4 | Experimental | acyanotic erythropoietin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acyanotic erythropoietin | Drug | Single dose IV push |
| |
| acyanotic placebo |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inotropic Support | 24 and 48 hours post operative | |
| Length of Hospitalization | At hospital discharge, up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Zangwill, MD | Children's Hospital and Health System Foundation, Wisconsin | Principal Investigator |
| John Baker, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15088102 | Background | 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. doi: 10.1007/s00395-004-0455-x. Epub 2004 Jan 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acyanotic Placebo | Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo |
| FG001 | Acyanotic Study Drug | Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acyanotic Placebo | Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo |
| BG001 | Acyanotic Study Drug | Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biochemical Markers of Heart Damage | Troponin I levels (ng/ml) measured at 4 time points | Analysis was limited to descriptive statistics due to low enrollment and study closure. | Posted | Mean | Standard Deviation | ng/ml | 4 postoperative time points up to 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acyanotic Placebo | Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | A brief post -op seizure occurred in a study participant who received placebo. There were no clinical sequelae. |
Analysis was limited to descriptive statistics due to low enrollment and study closure. The number of participants fell far short of study goals and the study was terminated prematurely due to inadequate enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Zangwill | Medical College of Wisconsin | 414-266-2380 | szangwill@chw.org |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Drug |
Single dose IV push |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Biochemical Markers of Neuron Damage | There were 43 samples taken from the 9 subjects but no analysis was performed - the laboratory did not set up the assay to run the samples because the study did not have enough subjects to achieve statistical power. | Posted | 4 postoperative time points |
|
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| Primary | Echocardiographic Assessment of Heart Function | These data were not collected. | Posted | 24 hours postop |
|
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| Secondary | Inotropic Support | These data were not collected | Posted | 24 and 48 hours post operative |
|
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| Secondary | Length of Hospitalization | Analysis was limited to descriptive statistics due to low enrollment and study closure. | Posted | Mean | Standard Deviation | days | At hospital discharge, up to 30 days |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Acyanotic Study Drug | Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug | 0 | 6 | 0 | 6 |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |