Summary

at San Diego, California
study started
estimated completion:
M.D` Justin C Yeh

Description

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.

Official Title

Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic Congenital Heart Disease - A Prospective Randomized Control Trial

Details

Congenital heart disease occurs in about 1% of all live births. Cyanotic cardiac lesions in particular are at risk for significant mortality and morbidity because of their reduced ability to provide adequate oxygenation to the body and the brain. Many experts believe that to have adequate oxygen carrying capacity that these infants should ideally have a hemoglobin level greater than 13 g/dL. Many of these patients require blood transfusions prior to surgery to provide adequate oxygenation. The cause for this is likely multifactorial including normal neonatal physiology, frequent lab draws, and co-morbidities. Although rare, the morbidity due to transfusions can be devastating to this population including transmitted infections, transfusion reactions, extra hospitalizations, and antigen sensitization that would complicate heart transplant if needed.

There are centers in the United States that have developed protocols using erythropoietin to minimize blood product transfusions before and after surgery, also referred to as "bloodless surgery". There have been retrospective studies evaluating the success of these protocols, but there are no randomized controlled prospective studies that the investigators have studying the effects of erythropoietin effects in patients with cyanotic heart disease in regards to transfusion prevention.

Congenital cyanotic cardiac patients require higher hemoglobin concentrations for optimal oxygen delivery. Prophylactic erythropoietin can prevent and/or decrease the amount of blood transfusions needed prior to surgery. The researchers seek to investigate if erythropoietin makes a clinically significant difference in the number of transfusions given to these patients and the morbidity associated with it.

Keywords

Cyanotic Congenital Heart Disease Anemia Cyanosis Congenital Heart Disease Erythropoetin Cyanotic Heart Disease Transfusion Heart Diseases Heart Defects, Congenital Iron Epoetin Alfa Epoetin Alfa and Iron Control Epoetin alfa and iron supplements

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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)

Location

  • Rady Children's Hospital accepting new patients
    San Diego California 92123 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02564796
Phase
Phase 2
Study Type
Interventional
Last Updated