Congenital Heart DefectEPONCT00451698

Erythropoietin and Pediatric Cardiac Surgery

A study testing acyanotic erythropoietin in people with Congenital Heart Defect, run by Medical College of Wisconsin at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 6 weeks to 18 years
Conditions the study is for: Congenital Heart Defect
What is being tested?: acyanotic erythropoietin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 weeks to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 6 weeks to 18 years
Requiring open heart surgery for congenital heart defect -Parents able to speak English and document informed consent -

Who cannot join

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 -

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

Read the 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.

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.

Conditions: Congenital Heart Defect
Being tested: acyanotic erythropoietin, acyanotic placebo
Keywords: Erythropoietin, Congenital heart surgery
Medical subject headings: Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acyanotic erythropoietinDrug
Single dose IV push
acyanotic placeboDrug
Single dose IV push

Study groups in NCT00451698
Study group	Role	What they receive
3	Placebo comparator	acyanotic placebo Receives: Drug: acyanotic placebo
4	Experimental	acyanotic erythropoietin Receives: Drug: acyanotic erythropoietin

What is being measured

The primary outcome is the main question the study is designed to answer.

Biochemical Markers of Heart Damage
Troponin I levels (ng/ml) measured at 4 time points
Measured: 4 postoperative time points up to 48 hours
Biochemical Markers of Neuron Damage
Measured: 4 postoperative time points
Echocardiographic Assessment of Heart Function
Measured: 24 hours postop

Secondary outcomes (2)

Inotropic Support
Measured: 24 and 48 hours post operative
Length of Hospitalization
Measured: At hospital discharge, up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Dec 2011

First posted23 Mar 2007 (estimated)
Study startOct 2007
Primary completionDec 2011
Study completionDec 2011

Why it stopped: Inadequate patient enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
More trials run by Medical College of WisconsinThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00451698
Sponsor's protocol ID: CHW 04/161
Acronym: EPO
Status last verified: Oct 2018
First submitted: 22 Mar 2007
Last updated: 8 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 15088102

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
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A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
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UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
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All Congenital Heart Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Erythropoietin and Pediatric Cardiac Surgery
ClinicalTrials.gov ID: NCT00451698
Acronym / sponsor ID: EPO / CHW 04/161
Conditions: Congenital Heart Defect
Keywords: Erythropoietin, Congenital heart surgery
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inadequate patient enrollment
Enrolment: 9 participants (actual)
Lead sponsor: Medical College of WisconsinUniversity, hospital or other
Collaborators: Children's Hospital and Health System Foundation, Wisconsin, National Center for Research Resources (NCRR)
Study start: Oct 2007
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 23 Mar 2007 (estimated)
Results: Posted 16 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

Detailed description

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
3	Placebo comparator	Drug: acyanotic placeboacyanotic placebo
4	Experimental	Drug: acyanotic erythropoietinacyanotic erythropoietin

Who may qualify

Ages: 6 weeks to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Age 6 weeks to 18 years
Requiring open heart surgery for congenital heart defect -Parents able to speak English and document informed consent -

Key exclusion criteria (3 listed)

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 -

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acyanotic erythropoietinSingle dose IV push	Drug	4
acyanotic placeboSingle dose IV push	Drug	3

Primary outcome

Biochemical Markers of Heart Damage
Time frame: 4 postoperative time points up to 48 hours
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

2 secondary outcomes

Inotropic Support
Time frame: 24 and 48 hours post operative
Length of Hospitalization
Time frame: At hospital discharge, up to 30 days

Results and safety

Results posted to the registry on 16 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acyanotic Placebo	3	3
Acyanotic Study Drug	6	6

Primary outcome: Biochemical Markers of Heart Damage

Time frame: 4 postoperative time points up to 48 hours. Mean (Standard Deviation). Unit: ng/ml

Measure	Acyanotic Placebo n = 3	Acyanotic Study Drug n = 6
60 minutes post bypass	31.1 (12.2)	12.3 (9.2)
4 hrs post bypass	27.2 (8.6)	15 (8.2)
24 hrs post bypass	10 (6.2)	10.7 (10.4)
48 hrs post bypass	5.2 (1.9)	5.2 (5.2)

Population analysed: Analysis was limited to descriptive statistics due to low enrollment and study closure.

Primary outcome: Biochemical Markers of Neuron Damage

Time frame: 4 postoperative time points

Population analysed: 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.

Primary outcome: Echocardiographic Assessment of Heart Function

Time frame: 24 hours postop

Population analysed: These data were not collected.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acyanotic Placebo	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Acyanotic Study Drug	0 of 6 (0%)	0 of 6 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15088102Shi 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.

Related trials for Congenital Heart Defect

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steve Zangwill, MD principal investigator

Children's Hospital and Health System Foundation, Wisconsin

John Baker, PhD principal investigator

Medical College of Wisconsin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing acyanotic erythropoietin in people with Congenital Heart Defect, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical Markers of Heart Damage (time frame: 4 postoperative time points up to 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00451698, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.