Comparison of Blood Sampling Methods for Hemoglobin Measurement

March 28, 2022 updated by: ICF Macro, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1082

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Ebenezer Lab
      • Kampala, Uganda
        • Uganda Bureau of Statistics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 49 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants will be children 6-59 months and non-pregnant women 15-49 years. In the controlled setting, participants will be selected from nearby communities and brought to the Ebenezer Lab in Kampala, Uganda. In the field setting, participants will be selected from households eligible for the DHS-8 questionnaire pilot in districts located near Kampala, Uganda.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controlled setting: single capillary and pooled capillary and venous blood
Single drop capillary blood, pooled capillary blood, and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a controlled setting.
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.
Field setting: single capillary and venous blood
Single drop capillary blood and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a field setting.
Device: 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.
Field setting: pooled capillary and venous blood
Pooled capillary blood and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a field setting.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin measurement
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICF Macro, Inc.

Collaborators

United States Agency for International Development (USAID)
Uganda Bureau of Statistics

Investigators

  • Principal Investigator: Sorrel ML Namaste, DrPH, ICF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Actual)

September 26, 2021

Study Completion (Actual)

September 26, 2021

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 720-OAA-18C-00083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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