Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03948516 |
| Other study ID # |
04-17-15 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 11, 2017 |
| Est. completion date |
April 26, 2018 |
Study information
| Verified date |
May 2022 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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
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.
