The goal of this project is to assess the feasibility, clinical effectiveness, and cost-effectiveness of IV iron therapy using ferric carboxymaltose (FCM) as a treatment for pediatric patients with iron deficiency anemia (IDA) in the emergency department (ED). The primary objectives are to: 1. examine and compare healthcare utilization and clinical outcomes of IV FCM use in the pediatric ED compared to historical cohort. 2. determine the feasibility of IV FCM in the pediatric ED. A secondary objective of this study is to evaluate if additional laboratory markers such as soluble transferrin receptor (sTfR) or reticulocyte hemoglobin equivalent can serve as potential surrogate markers for diagnosing and monitoring treatment response of IDA between oral iron and IV FCM. By evaluating clinical outcomes such as the time to resolution of anemia, hospitalization rates and need for PRBC transfusion, assessing the feasibility of FCM implementation, and secondarily exploring potential adjunct markers for monitoring IDA, this study aims to fill the current research gap and potentially revolutionize management of IDA in pediatric emergency care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose
Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation
Time to resolution of anemia
days to normalization of Hgb with treatment
Time frame: 6 months
Need for blood transfusions
Volume of blood transfused
Time frame: 6 months
Rates of Hospitalizations
Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia
Time frame: 6 months
Re-presentation rates
The number of patients enrolled on the study that re-present to the ED for ongoing care of their anemia
Time frame: 6 months
Time spent in the Emergency department
Length of stay measured, in hours, in the emergency department.
Time frame: 6 months
Adverse reaction to interventional treatment
Side effects of treatment with iron
Time frame: 6 months
Treatment tolerability
Adherence to oral iron therapy
Time frame: 6 months
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