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NCT07414199Not yet recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
150 (estimated)
First submitted
9 Dec 2025
Start date
31 Jan 2026
Primary completion date
30 Jun 2026
Lead sponsor
Children's Hospital of Orange County
NCT number
NCT07414199

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 150
  • From 31 Jan 2026 to the primary completion date, 30 Jun 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Overt Bleeding (excluding menstrual bleeding)
  • Malignancy
  • Active infection

Lab values

  • Patients with normal Hb or Hb \<6 g/dL
  • Thrombocytopenia (platelets \<100k)

Age

  • Patients \<1 year or \> 18 years of age

Other

  • Traumatic etiology for blood loss

Who the study is looking for

  • 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

Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.