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临床试验/NCT05153278
NCT05153278已完成不适用

Effectiveness and Impact of Intravenous Iron Versus Standard Treatment in Treating Iron Deficiency Anemia in the Emergency Department at University Medical Center

Texas Tech University Health Sciences Center, El Paso1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2018年10月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
Change in hemoglobin

研究概览

简要总结

The investigators will retrospectively collect data of patients infused at UMC's emergency department (ED) with long acting irons (ferric carboxymaltose, iron dextran, iron sucrose, etc.), in addition, patients infused with blood products, with intent to treat iron deficiency anemia (IDA). Patient records reviewed will be from patients who were infused at UMC ED from January 2013 to June 2018. Primary aim of analysis will be to investigate superiority between interventions implemented for treating IDA. In addition, the investigators will utilize data to characterize patients who used ED services as an avenue to receive treatment for IDA. Further, the investigators will conduct cost analysis between different IDA directed treatments administered in the ED at UMC.

详细描述

Background:

Iron deficiency anemia (IDA) is a condition that impacts approximately 2-billion people globally, and impacts individuals from all socioeconomic backgrounds, making it one of the most common nutritional disorders in the world. In any population, women and children are the groups that are more susceptible to suffering from IDA [3]. IDA has broad influences on the health of an individual, ranging from cognitive decline to motor deficits. When coupled with pregnancy, IDA has been shown to be associated with low birth weight and carries an increased risk of maternal and perinatal mortality. In addition to women and children, the prevalence of IDA has been found to increase with age, and with chronic disease. The approach to treating IDA regularly begins with oral iron supplementation. However, due to increased gastrointestinal side effects or excessive losses of iron, intravenous iron has been shown to be better tolerated. Further, intravenous iron is another attractable iron replacement strategy in IDA when the need for rapid delivery is required, such as in pregnancy or following traumas. When compared to blood products, intravenous iron is an attractive option due to its ready availability. With a growing and aging population it is important that major health problems such as IDA be investigated further in order to identify sustainable therapeutic strategies.

Benefits of Study:

This retrospective study will provide the investigators with valuable knowledge on which treatment for IDA may be most effective in treating our El Paso population of patients suffering from IDA (Primary Aim). This study will also allow the investigators to identify which IDA treatment is most cost effective (Secondary Aim A), and which population of the community would benefit the most from an outpatient infusion service (Secondary Aim B).

Chart Inclusion Criteria:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving one IDA intervention in the UMC ED who had at least one complete blood count or hemoglobin after discharge from the emergency department or hospital

排除标准

  • Patients with no records of follow up

研究组 & 干预措施

Control group

Patients that received standard treatment (packed red blood cells) for iron deficiency anemia

干预措施: Packed red blood cells (Biological)

Experimental group

Patients that received intravenous iron instead of standard treatment (packed red blood cells) for iron deficiency anemia

干预措施: Intravenous drug (Drug)

结局指标

主要结局

Change in hemoglobin

时间窗: 180 days

Change in serum hemoglobin over time

次要结局

  • Change in MCV (mean corpuscular volume)(180 days)

研究者

发起方
Texas Tech University Health Sciences Center, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Patek, MD

Assistant Professor

Texas Tech University Health Sciences Center, El Paso

研究点 (1)

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