The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Need for blood transfusions
研究概览
简要总结
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:
- examine and compare healthcare utilization and clinical outcomes of IV FCM use in the pediatric ED compared to historical cohort.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Newly diagnosed iron deficiency anemia
Participants receive oral iron supplementation
干预措施: Ferrous Sulfate (Drug)
Recurrent or refractory iron deficiency anemia
Participants are randomized to receive oral iron supplementation or IV Ferric carboxymaltose
干预措施: Ferric Carboxymaltose (FCM) (Drug)
结局指标
主要结局
Need for blood transfusions
时间窗: 6 months
Volume of blood transfused
Rates of Hospitalizations
时间窗: 6 months
Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia
Re-presentation rates
时间窗: 6 months
The number of patients enrolled on the study that re-present to the ED for ongoing care of their anemia
Time to resolution of anemia
时间窗: 6 months
days to normalization of Hgb with treatment
次要结局
- Time spent in the Emergency department(6 months)
- Adverse reaction to interventional treatment(6 months)
- Treatment tolerability(6 months)
研究者
Maritza Ruiz
Physician Attending
Children's Hospital of Orange County