Sickle Cell Disease, Hemechip

Completed

Conditions studied: Sickle Cell Disease

In brief

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

Key facts

Study ID

NCT03948516

Run by

University Hospitals Cleveland Medical Center

People needed

738

Starts

2017-07-11

Expected to finish

2018-04-26

Last updated by the study team

2025-08-21

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Aminu Kano Teaching Hospital — Kano, Nigeria
• Hasiya Bayero Pediatric Hospital — Kano, Nigeria
• Murtala Mohammed Specialist Hospital — Kano, Nigeria

Full record on ClinicalTrials.gov

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