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, Iron Deficiency Anemias
Conditions
Keywords
Iron deficiency, anemia, ferric carboxymaltose
Brief 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.
Interventions
Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose
DRUGFerrous Sulfate
Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation
Sponsors
Children's Hospital of Orange County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to resolution of anemia | 6 months | days to normalization of Hgb with treatment |
| Need for blood transfusions | 6 months | Volume of blood transfused |
| Rates of Hospitalizations | 6 months | Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia |
| Re-presentation rates | 6 months | The number of patients enrolled on the study that re-present to the ED for ongoing care of their anemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in the Emergency department | 6 months | Length of stay measured, in hours, in the emergency department. |
| Adverse reaction to interventional treatment | 6 months | Side effects of treatment with iron |
| Treatment tolerability | 6 months | Adherence to oral iron therapy |
Contacts
CONTACTManager, Clinical Research Programs
Outcome results
None listed