Sickle Cell DiseaseNCT03948516
Sickle Cell Disease, Hemechip
An observational study of Sickle Cell Disease, run by University Hospitals Cleveland Medical Center at 7 sites in 2 countries.
Trial summary
Sickle cell disease is very common in Nigeria. Early diagnosis is important to prevent or reduce serious complications from the disease and to enable children stay healthy. To this end, the investigators would like to test a new, simple and quick device called the HemeChip to determine if it can detect whether or not… Read more about this study
- Who is it for?
- Ages 6 weeks to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 738 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 11 Jul 2017to 26 Apr 2018
- 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 weeks to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants and children aged 6 weeks to 60 months
Who may be able to join
- Fever or hypothermia (Temp ≥38 C or ≤36 C) Plus one of the following (prostration, excessive crying, poor feeding, altered consciousness, convulsion, difficulty breathing, profuse vomiting, diarrhea) \& rapid breathing (0-2months>60 breaths/min, 3-12months >50 breaths/min, 13- 59 months > 40 breaths /min)
- Provision of signed and dated written informed consent by parent or guardian
Who cannot join
- Parent of child chooses to opt out of the study after initial consent.
- Blood transfusion within 3 months of study enrollment.
- Presence of condition or abnormality that in the opinion of the investigator would compromise the safety of the child or the quality of the data.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Case Western Reserve University
Cleveland, Ohio, 44106
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Nigeria3 sites
Aminu Kano Teaching Hospital
Kano
Hasiya Bayero Pediatric Hospital
Kano
Murtala Mohammed Specialist Hospital
Kano
About this study
Official title: Validation of a Point-of-care Screening Tool for Children With Sickle Cell Disease
Sickle cell disease is very common in Nigeria. Early diagnosis is important to prevent or reduce serious complications from the disease and to enable children stay healthy. To this end, the investigators would like to test a new, simple and quick device called the HemeChip to determine if it can detect whether or not someone has sickle cell disease. The investigators will compare the results obtained with the HemeChip with a standard method of diagnosing sickle cell disease known as Isoelectric focusing (IEF) or High Performance Liquid Chromatography (HPLC).If the investigators show that the new device can differentiate between children who have sickle cell disease and those who don't as successfully as the IEF or HPLC, they estimate a sharp increase in the use of this device in many countries especially in Africa due to its lower cost
Read the detailed description
Sickle cell disease (SCD) is a group of inherited disorders of haemoglobin (Hb) synthesis, first described in the medical literature by James Herrick in 1910. Each year about 300,000 infants are born with SCD, including more than 200,000 cases in subSaharan Africa alone. In Nigeria alone, there are over 150,000 of these children born annually and it is estimated that between 50-90% of these children die before their fifth birthday. Overall, in the region, 6% of all childhood mortality in children less than 5 years of age is due to SCD complications and infections. Vaso occlusive crisis and anemia are serious complications of SCD, with infection often being the major cause of hospitalizations, crisis and death. SCD is caused by a point mutation in the sixth codon of the beta globin chain that produces normal Hb (HbA). This substitution of hydrophilic glutamic acid with hydrophobic valine produces sickle Hb (HbS), which is abnormally polymerized at low oxygen conditions causing sickling. Abnormal polymerization of HbS affects red cell membrane properties, shape, and density, and subsequent critical changes in inflammatory cell and endothelial cell function.
The clinical consequences of SCD include painful crises, widespread organ damage, and early mortality. Current standard practices for diagnosing SCD are high performance liquid chromatography (HPLC) and bench-top Hb electrophoresis. These two approaches, however, require trained personnel and state-of-the-art facilities, both of which may be lacking in many parts of sub-Saharan Africa where the disease is most prevalent.
These laboratory methods also carry significant costs which may be unaffordable for most patients. HemeChip diagnostic system offers an original and innovative solution, leveraging a novel engineering approach, to point of care (POC) diagnosis of SCD. HemeChip separates haemoglobin protein types in a miniscule volume of blood (1μL) on a piece of cellulose acetate paper that is housed in a micro-engineered chip with a controlled environment and electric field. Differences in Hb mobilities allow separation to occur within the cellulose acetate paper. A micro-engineered design and multiple layer lamination approach are utilized in fabricating the HemeChip. The design allows rapid manual assembly and results are available within a few minutes of performing the test.
HemeChip can also integrate with a mobile user interface (e.g. IPhone, IPod), which shows the test result quantitatively and objectively on the screen. HemeChip can be used by anyone after a short (30 minute) training, eliminating the need for highly skilled personnel.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants tested for Sickle cell disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the HemeChip technology as a novel, point-of-care (POC) platform for screening SCD.
The results obtained using the HemeChip will be compared to High Performance Liquid Chromatography (HPLC), and the sensitivity and specificity of the HemeChip will be determined.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start11 Jul 2017
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Prospective
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- US federal government, University of Nebraska, University of North Carolina, Chapel Hill, Case Western Reserve University, Aminu Kano Teaching Hospital, Nigeria, Murtala Muhammad Specialist Hospital, Nigeria, Hasiya Bayero Hospital, Nigeria
- Responsible party
- Principal investigator, AOwusu-Ansah, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948516
- Sponsor's protocol ID
- 04-17-15
- Status last verified
- Aug 2025
- First submitted
- 1 May 2019
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Point-of-care Screening Tool for Children With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03948516
- Acronym / sponsor ID
- 04-17-15
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- US federal government, University of Nebraska, University of North Carolina, Chapel Hill, Case Western Reserve University, Aminu Kano Teaching Hospital, Nigeria, Murtala Muhammad Specialist Hospital, Nigeria, Hasiya Bayero Hospital, Nigeria
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 14 May 2019 (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.
Sickle cell disease is very common in Nigeria. Early diagnosis is important to prevent or reduce serious complications from the disease and to enable children stay healthy. To this end, the investigators would like to test a new, simple and quick device called the HemeChip to determine if it can detect whether or not someone has sickle cell disease. The investigators will compare the results obtained with the HemeChip with a standard method of diagnosing sickle cell disease known as Isoelectric focusing (IEF) or High Performance Liquid Chromatography (HPLC).If the investigators show that the new device can differentiate between children who have sickle cell disease and those who don't as successfully as the IEF or HPLC, they estimate a sharp increase in the use of this device in many countries especially in Africa due to its lower cost
Detailed description
Sickle cell disease (SCD) is a group of inherited disorders of haemoglobin (Hb) synthesis, first described in the medical literature by James Herrick in 1910. Each year about 300,000 infants are born with SCD, including more than 200,000 cases in subSaharan Africa alone. In Nigeria alone, there are over 150,000 of these children born annually and it is estimated that between 50-90% of these children die before their fifth birthday. Overall, in the region, 6% of all childhood mortality in children less than 5 years of age is due to SCD complications and infections. Vaso occlusive crisis and anemia are serious complications of SCD, with infection often being the major cause of hospitalizations, crisis and death. SCD is caused by a point mutation in the sixth codon of the beta globin chain that produces normal Hb (HbA). This substitution of hydrophilic glutamic acid with hydrophobic valine produces sickle Hb (HbS), which is abnormally polymerized at low oxygen conditions causing sickling. Abnormal polymerization of HbS affects red cell membrane properties, shape, and density, and subsequent critical changes in inflammatory cell and endothelial cell function.
The clinical consequences of SCD include painful crises, widespread organ damage, and early mortality. Current standard practices for diagnosing SCD are high performance liquid chromatography (HPLC) and bench-top Hb electrophoresis. These two approaches, however, require trained personnel and state-of-the-art facilities, both of which may be lacking in many parts of sub-Saharan Africa where the disease is most prevalent.
These laboratory methods also carry significant costs which may be unaffordable for most patients. HemeChip diagnostic system offers an original and innovative solution, leveraging a novel engineering approach, to point of care (POC) diagnosis of SCD. HemeChip separates haemoglobin protein types in a miniscule volume of blood (1μL) on a piece of cellulose acetate paper that is housed in a micro-engineered chip with a controlled environment and electric field. Differences in Hb mobilities allow separation to occur within the cellulose acetate paper. A micro-engineered design and multiple layer lamination approach are utilized in fabricating the HemeChip. The design allows rapid manual assembly and results are available within a few minutes of performing the test.
HemeChip can also integrate with a mobile user interface (e.g. IPhone, IPod), which shows the test result quantitatively and objectively on the screen. HemeChip can be used by anyone after a short (30 minute) training, eliminating the need for highly skilled personnel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants tested for Sickle cell disease | – | – |
Who may qualify
- Ages
- 6 weeks to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants and children aged 6 weeks to 60 months
Key inclusion criteria (2 listed)
- Fever or hypothermia (Temp ≥38 C or ≤36 C) Plus one of the following (prostration, excessive crying, poor feeding, altered consciousness, convulsion, difficulty breathing, profuse vomiting, diarrhea) \& rapid breathing (0-2months>60 breaths/min, 3-12months >50 breaths/min, 13- 59 months > 40 breaths /min)
- Provision of signed and dated written informed consent by parent or guardian
Key exclusion criteria (3 listed)
- Parent of child chooses to opt out of the study after initial consent.
- Blood transfusion within 3 months of study enrollment.
- Presence of condition or abnormality that in the opinion of the investigator would compromise the safety of the child or the quality of the data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the HemeChip technology as a novel, point-of-care (POC) platform for screening SCD.
Time frame: 30 minutes
The results obtained using the HemeChip will be compared to High Performance Liquid Chromatography (HPLC), and the sensitivity and specificity of the HemeChip will be determined.
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 21 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by University Hospitals Cleveland Medical Center at 7 sites in 2 countries.
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 2 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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Nigeria. 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?
Validation of the HemeChip technology as a novel, point-of-care (POC) platform for screening SCD. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2025.