About this trial
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.
Eligibility criteria
Qualifiers
1 year to 18 years of age
Lab results indicative of anemia due to iron deficiency with Hb between 6.0 g/dL-10.0 g/dL for age and gender
Patient is hemodynamically stable
Disqualifiers
Patients <1 year or > 18 years of age
Patients with normal Hb or Hb <6 g/dL
Overt Bleeding (excluding menstrual bleeding)
Traumatic etiology for blood loss
Trial design
Treatments tested in this trial
- Ferric Carboxymaltose (FCM)
- Ferrous Sulfate