NCT05059457已完成不适用
A Pilot to Asses Hemoglobin Concentration Obtained From Capillary and Venous Blood Measured Using the HemoCue 201+ Hemoglobin Analyzer in a Controlled and Field Setting
ICF Macro, Inc.2 个研究点 分布在 1 个国家目标入组 1,082 人开始时间: 2021年8月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,082
- 试验地点
- 2
- 主要终点
- Hemoglobin measurement
研究概览
简要总结
This study is designed to inform The DHS Program on whether there are variations in hemoglobin concentration using the DHS standard technique of a single drop of capillary blood and alternative blood sources (pooled capillary and venous blood) using the HemoCue 201+ analyzer compared to venous blood using a clinical hematology autoanalyzer.
Research Objectives:
- To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) and a pooled drop of capillary blood measured on the HemoCue 201+ analyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled setting (i.e., blood specimens are collected in a laboratory setting).
- To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
- To determine if there are differences in the hemoglobin concentration between a pooled drop of capillary blood measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
- To compare results of hemoglobin distribution and estimates of anemia prevalence using two types of capillary blood (single drop and pooled) and venous blood measured on the HemoCue 201+ analyzer and a clinical autoanalyzer using venous blood in a controlled and field setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 49 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6-59 months or non-pregnant women 15-49
- •Apparently healthy individuals
- •Consent to participate in the study
排除标准
- •Children less than 6 months or over 59 months
- •Women less than 15 years of age or greater than 49 years of age
- •Pregnant women
结局指标
主要结局
Hemoglobin measurement
时间窗: Day 1
Difference (correlation, concordance, paired t-test) in hemoglobin concentration between each blood source measured with the HemoCue 201+ compared to venous blood measured with a clinical autoanalyzer.
次要结局
未报告次要终点
研究者
研究点 (2)
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