TerminatedPhase 2

Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic CHD - A Prospective Control Trial

Stopped: COVID

United States4 participantsStarted 2016-11

Plain-language summary

Cyanotic congenital cardiac patients require higher hemoglobin concentrations (red blood cell levels) for optimal oxygen delivery to the body. Prophylactic erythropoietin (EPO) and iron can prevent and/or decrease the amount of blood transfusions needed in this population. We seek to investigate if EPO and iron make a clinically significant difference in the number of transfusions given to these patients and the morbidity associated with it.

Who can participate

Age range

8 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Newborns less than 4 weeks old at diagnosis * Gestational age \>34 weeks * Birth weight 2.2-4kg * Cyanotic heart disease who have had a surgical shunt or a catheterization intervention that is equivalent to a shunt (patent ductus arteriosus stent, right ventricular outflow tract stent). * Baseline hematocrit to be below \<40%. * Completes at least 1 injection in the study by 8 weeks of age. Exclusion Criteria * Infants diagnosed at greater than 4 weeks of age * Gestation \<34 weeks * Birth weight \<2.2 kg or \>4kg * Hematocrit \>40% * Newborns with acyanotic heart disease * Infants with significant co-morbidities: * Renal failure (Creatinine \> 2 standard deviations above age adjusted norm) * Hepatic failure (elevated AST/ALT levels \> 2 standard deviations above age adjusted norm * Hemolytic disease * Hemoglobinopathies (Sickle-cell disease, Thalassemias)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Transfusions Needed

Timeframe: First 4 months of life

Trial details

NCT IDNCT02564796

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06

Results submitted2021-11-03

View on ClinicalTrials.gov More Cyanotic Congenital Heart Disease trials