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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05059457
Other study ID # 720-OAA-18C-00083
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 23, 2021
Est. completion date September 26, 2021

Study information

Verified date March 2022
Source ICF Macro, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Blood source: single and pooled capillary and venous blood
A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+. Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+. Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.
Blood source: single capillary and venous blood
A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+ . Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.
Blood source: pooled capillary and venous blood
Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+. Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.

Locations

Country Name City State
Uganda Ebenezer Lab Kampala
Uganda Uganda Bureau of Statistics Kampala

Sponsors (3)

Lead Sponsor Collaborator
ICF Macro, Inc. Uganda Bureau of Statistics, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Uganda, 

Outcome

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
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