Anemia Clinical Trial
Official title:
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
Verified date | March 2022 |
Source | ICF Macro, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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: 1. 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). 2. 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. 3. 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. 4. 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.
Status | Completed |
Enrollment | 1082 |
Est. completion date | September 26, 2021 |
Est. primary completion date | September 26, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Months to 49 Years |
Eligibility | Inclusion Criteria: - Children 6-59 months or non-pregnant women 15-49 - Apparently healthy individuals - Consent to participate in the study Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Uganda | Ebenezer Lab | Kampala | |
Uganda | Uganda Bureau of Statistics | Kampala |
Lead Sponsor | Collaborator |
---|---|
ICF Macro, Inc. | Uganda Bureau of Statistics, United States Agency for International Development (USAID) |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin measurement | 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. | Day 1 |
Status | Clinical Trial | Phase | |
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Terminated |
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