AnemiaNCT05059457
Comparison of Blood Sampling Methods for Hemoglobin Measurement
An observational study of Anemia, run by ICF Macro, Inc. at 2 sites in Uganda.
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… Read more about this study
- Who is it for?
- Ages 6 months to 49 years
- Conditions the study is for
- Anemia
- What is being tested?
- Blood source: single and pooled capillary and venous blood, Blood source: single capillary and venous blood and Blood source: pooled capillary and venous blood
- Type of treatment
- Medical device
- How many people
- 1,082 participants
- Where
- 2 sitesUganda
- Study dates
- 23 Aug 2021to 26 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 49 years
- All sexes
- Child, Adult
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.
Who may be able to join
- Children 6-59 months or non-pregnant women 15-49
- Apparently healthy individuals
- Consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Anemia
- Being tested
- Blood source: single and pooled capillary and venous blood, Blood source: single capillary and venous blood, Blood source: pooled capillary and venous blood
- Keywords
- Anemia, DHS surveys, Point-of-care, Hemoglobin, Survey methods
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood source: single and pooled capillary and venous bloodDevice
- 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 bloodDevice
- 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 bloodDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blood source: single and pooled capillary and venous blood | |
| 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. Receives: Device: Blood source: single capillary and venous blood | |
| 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. Receives: Device: Blood source: pooled capillary and venous blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start23 Aug 2021
- Primary completion26 Sep 2021
- Study completion26 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICF Macro, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Uganda Bureau of Statistics
- Responsible party
- Sponsor
- Investigators
- Sorrel ML Namaste, DrPH, Principal investigator, ICF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059457
- Sponsor's protocol ID
- 720-OAA-18C-00083
- Status last verified
- Mar 2022
- First submitted
- 17 Sep 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Namaste SM, Baingana R, Brindle E. Hemoglobin measurement in venous blood compared with pooled and single-drop capillary blood: a method-comparison study in a controlled and survey setting in Uganda among children and women. Am J Clin Nutr. 2024 Apr;119(4):949-959. doi: 10.1016/j.ajcnut.2023.12.025. Epub 2024 Jan 3.
PubMed 38176682
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05059457
- Acronym / sponsor ID
- 720-OAA-18C-00083
- Conditions
- Anemia
- Keywords
- Anemia, DHS surveys, Point-of-care, Hemoglobin, Survey methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,082 participants (actual)
- Lead sponsor
- ICF Macro, Inc.University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Uganda Bureau of Statistics
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 26 Sep 2021 (actual)
- Study completion
- 26 Sep 2021 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlled setting: single capillary and pooled capillary and venous blood | – | Device: Blood source: single and pooled capillary and venous bloodSingle 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. |
| Field setting: single capillary and venous blood | – | Device: Blood source: single capillary and venous bloodSingle 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. |
| Field setting: pooled capillary and venous blood | – | Device: Blood source: pooled capillary and venous bloodPooled 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. |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Children 6-59 months or non-pregnant women 15-49
- Apparently healthy individuals
- Consent to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Controlled setting: single capillary and pooled capillary and venous blood |
| 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. | Device | Field setting: single capillary and venous blood |
| 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. | Device | Field setting: pooled capillary and venous blood |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 38176682Namaste SM, Baingana R, Brindle E. Hemoglobin measurement in venous blood compared with pooled and single-drop capillary blood: a method-comparison study in a controlled and survey setting in Uganda among children and women. Am J Clin Nutr. 2024 Apr;119(4):949-959. doi: 10.1016/j.ajcnut.2023.12.025. Epub 2024 Jan 3.
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
Sickle Cell Disease, Sickle Cell Anaemia
RecruitingPhase 2
Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis
Severe Aplastic Anemia (SAA), Hypo-Plastic Myelodysplastic Syndrome (MDS)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sorrel ML Namaste, DrPH principal investigator
ICF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by ICF Macro, Inc. at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin measurement (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.