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

• Status: Active, not recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Epoetin Alfa; Iron

Criteria

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)