Validation of a Point-of-care Screening Tool for Children With Sickle Cell Disease

Study point of contact

Umut Gurkan, PhD
(216) 368-6447
[email protected]
Jane Little, MD
216-844-3042
[email protected]

Locations

4 United States sites

3 Nigeria sites

Age

6 to 60 Years

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Device

Compensation


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About the study

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

study participation requirements

– 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

study participation exclusions

– 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.

Location

  • University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198 [Active, not recruiting]
  • University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599 [Active, not recruiting]
  • Case Western Reserve University, Cleveland, Ohio, United States, 44106 [Active, not recruiting]
  • University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106 [Active, not recruiting]
  • Aminu Kano Teaching Hospital, Kano, Nigeria [Recruiting]
  • Hasiya Bayero Pediatric Hospital, Kano, Nigeria [Recruiting]
  • Murtala Mohammed Specialist Hospital, Kano, Nigeria [Recruiting]

More info

View on ClinicalTrials.gov
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