drugset / Trial / NCT07414199

The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department

NCT07414199

Phase 4 Not yet recruiting 150 enrolled Children's Hospital of Orange County
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-01-31
Primary completion
2026-06-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent