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

ConditionsIron 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 Iron Deficiency Anemias

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age1-18

SponsorChildren's Hospital of Orange County

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Ferric Carboxymaltose (FCM)
Drug
Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose
Ferrous Sulfate
Drug
Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Newly diagnosed iron deficiency anemiaActive comparator 1 intervention

Group B: Recurrent or refractory iron deficiency anemiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Time to resolution of anemia

days to normalization of Hgb with treatment

Time frame

6 months

Need for blood transfusions

Volume of blood transfused

Time frame

6 months

Rates of Hospitalizations

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

Time frame

6 months

Re-presentation rates

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

Time frame

6 months

Secondary outcomes

Time spent in the Emergency department

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

Time frame

6 months

Adverse reaction to interventional treatment

Side effects of treatment with iron

Time frame

6 months

Treatment tolerability

Adherence to oral iron therapy

Time frame

6 months

Other outcomes

Changes in laboratory biomarkers

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

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Orange County

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: