Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948516
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
US federal government
Amino Kano Teaching Hospital
Murtala Mohammed Specialist Hospital
Hasiya Bayero Pediatric Hospital
University of Nebraska
University of North Carolina, Chapel Hill
Case Western Reserve University
Information provided by (Responsible Party):
Jane Little, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE July 11, 2017
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sickle Cell Disease, Hemechip
Official Title  ICMJE Validation of a Point-of-care Screening Tool for Children With Sickle Cell Disease
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
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Device: HemeChip
The basis of HemeChip technology lies in Hb electrophoresis, in which Hb types C, A2, S, F, and A0 have net negative charges in an alkaline solution. Differences in Hb mobilities allow separation to occur within the sieving medium, cellulose acetate paper. HemeChip technology is a low-cost, point-of-care translation of the electrophoresis method that has been well established, readily accepted by clinicians, and widely applied in SCD diagnosis for well over 40 years. HemeChip offers a $2 screening test for SCD (and other Hb disorders), which takes 10 minutes to run. It is mobile and easy-to-use; it can be performed by anyone after a short (30 minute) training.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
5000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 60 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jane Little, MD 216-844-3042 jane.little@uhhospitals.org
Contact: Umut Gurkan, PhD (216) 368-6447 umut@case.edu
Listed Location Countries  ICMJE Nigeria,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948516
Other Study ID Numbers  ICMJE 04-17-15
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane Little, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE
  • US federal government
  • Amino Kano Teaching Hospital
  • Murtala Mohammed Specialist Hospital
  • Hasiya Bayero Pediatric Hospital
  • University of Nebraska
  • University of North Carolina, Chapel Hill
  • Case Western Reserve University
Investigators  ICMJE Not Provided
PRS Account University Hospitals Cleveland Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP