Sickle Cell Disease, Hemechip

NCT03948516 | Completed

• 1 other identifier: 04-17-15
• Study Type: observational
• Target: 738
• Locations: 2 countries
• Sites: 7

Brief 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

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes

Study Arms (1)

Participants tested for Sickle cell disease

Eligibility Criteria

• Age: 6 Weeks - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants and children aged 6 weeks to 60 months

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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• US federal government: collaborator
• University of Nebraska: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Case Western Reserve University: collaborator
• Aminu Kano Teaching Hospital, Nigeria: collaborator
• Murtala Muhammad Specialist Hospital, Nigeria: collaborator
• Hasiya Bayero Hospital, Nigeria: collaborator

Study Sites (7)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Aminu Kano Teaching Hospital

Kano, Nigeria

Location

Hasiya Bayero Pediatric Hospital

Kano, Nigeria

Location

Murtala Mohammed Specialist Hospital

Kano, Nigeria

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 14, 2019
• Study Start: July 11, 2017
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

NG (3); US (4)