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NCT Number: NCT07414199

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

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.

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Key information

Conditions

Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anaemia Due to Dietary Causes Iron Deficiency Anemia Secondary to IBD or Gastric Bypass Iron Deficiency Anemia Treatment Iron Deficiency Anemias Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Malignancy
  • Thrombocytopenia (platelets <100k)
  • Active infection

Treatment and study plan

Ferric Carboxymaltose (FCM)

Drug

Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose

Other names: injectafer

Ferrous Sulfate

Drug

Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation

Other names: fer-in-sol, slow Fe

Primary outcomes

  1. Time to resolution of anemia

    Time frame: 6 months

    days to normalization of Hgb with treatment

  2. Need for blood transfusions

    Time frame: 6 months

    Volume of blood transfused

  3. Rates of Hospitalizations

    Time frame: 6 months

    Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia

  4. Re-presentation rates

    Time frame: 6 months

    The number of patients enrolled on the study that re-present to the ED for ongoing care of their anemia

Secondary outcomes

  1. Time spent in the Emergency department

    Time frame: 6 months

    Length of stay measured, in hours, in the emergency department.

  2. Adverse reaction to interventional treatment

    Time frame: 6 months

    Side effects of treatment with iron

  3. Treatment tolerability

    Time frame: 6 months

    Adherence to oral iron therapy

Other outcomes

  1. Changes in laboratory biomarkers

    Time frame: 6 months

    Associated changes in soluble transferrin receptor and reticulocyte hemoglobin equivalent during treatment for iron deficiency anemia

Study contacts

Contact information is provided by the study sponsor or research team.

Manager, Clinical Research Programs

CONTACT

[email protected]

714-509-3742

Sponsors and collaborators

Lead sponsor

Children's Hospital of Orange County

Other

Registry information

Acronym: ED-Heme FCM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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