Sickle Cell Disease, Hemechip
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03948516|
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 26, 2022
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|Condition or disease|
|Sickle Cell Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||738 participants|
|Official Title:||Validation of a Point-of-care Screening Tool for Children With Sickle Cell Disease|
|Actual Study Start Date :||July 11, 2017|
|Actual Primary Completion Date :||April 26, 2018|
|Actual Study Completion Date :||April 26, 2018|
|Participants tested for Sickle cell disease|
- Validation of the HemeChip technology as a novel, point-of-care (POC) platform for screening SCD. [ Time Frame: 30 minutes ]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.
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|Ages Eligible for Study:||6 Weeks to 60 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948516
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Aminu Kano Teaching Hospital|
|Hasiya Bayero Pediatric Hospital|
|Murtala Mohammed Specialist Hospital|
Documents provided by AOwusu-Ansah, University Hospitals Cleveland Medical Center:
|Responsible Party:||AOwusu-Ansah, Physician, University Hospitals Cleveland Medical Center|
|Other Study ID Numbers:||
|First Posted:||May 14, 2019 Key Record Dates|
|Last Update Posted:||May 26, 2022|
|Last Verified:||May 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn