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| ID | Type | Description | Link |
|---|---|---|---|
| 16977021 | Other Grant/Funding Number | Pediatric Subspecialty Faculty Grant |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly diagnosed iron deficiency anemia | Active Comparator | Participants receive oral iron supplementation |
|
| Recurrent or refractory iron deficiency anemia | Experimental | Participants are randomized to receive oral iron supplementation or IV Ferric carboxymaltose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Drug | Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of anemia | days to normalization of Hgb with treatment | 6 months |
| Need for blood transfusions | Volume of blood transfused | 6 months |
| Rates of Hospitalizations | Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in the Emergency department | Length of stay measured, in hours, in the emergency department. | 6 months |
| Adverse reaction to interventional treatment | Side effects of treatment with iron |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in laboratory biomarkers | Associated changes in soluble transferrin receptor and reticulocyte hemoglobin equivalent during treatment for iron deficiency anemia | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Research Programs | Contact | 714-509-3742 | shelby.shelton@choc.org |
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|
| Ferrous Sulfate | Drug | Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation |
|
|
| 6 months |
| Treatment tolerability | Adherence to oral iron therapy | 6 months |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| C020748 | ferrous sulfate |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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