| Umut Gurkan, PhD | |
| (216) 368-6447 | |
| [email protected] |
| Jane Little, MD | |
| 216-844-3042 | |
| [email protected] |
4 United States sites
3 Nigeria sites
6 to 60 Years
N/A
Interventional
All
Device
Unknown
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
– 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
– 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.