The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferric Carboxymaltose (FCM), Ferrous Sulfate.
- Who it may be relevant to
- Registry conditions: Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia Secondary to IBD or Gastric Bypass. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Ferric Carboxymaltose (FCM)
Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose - Drug Ferrous Sulfate
Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation
Primary outcome measures
- Time to resolution of anemia [Time frame: 6 months]
- Need for blood transfusions [Time frame: 6 months]
- Rates of Hospitalizations [Time frame: 6 months]
- Re-presentation rates [Time frame: 6 months]
Secondary outcome measures (3)
- Time spent in the Emergency department [Time frame: 6 months]
- Adverse reaction to interventional treatment [Time frame: 6 months]
- Treatment tolerability [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07414199 · 2510122 · 16977021