NCT04758208

Brief Summary

This study is a collaborative initiative between the CALIPER (Canadian Laboratory Initiative on Pediatric Reference Intervals) program at the Hospital for Sick Children (HSC) and Mindray Medical International Limited to establish a database of pediatric reference intervals for hematology parameters on BC-6800Plus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
691

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

February 8, 2021

Last Update Submit

March 8, 2022

Conditions

Establish Hematology Reference Intervals

Outcome Measures

Primary Outcomes (37)

  • White Blood Cell count

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Basophil number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Basophil percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Neutrophil number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Neutrophil percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Eosinophil number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Eosinophil percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Lymphocyte number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Lymphocyte percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Monocyte number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Monocyte percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Immature Granulocyte number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Immature Granulocyte percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Reticulocyte percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Reticulocyte number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Reticulocyte Hemoglobin Expression

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Immature reticulocyte fraction

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Low fluorescent ratio

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Middle fluorescent ratio

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • High fluorescent ratio

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Red blood cell count

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Hemoglobin Concentration

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Mean Corpuscular Volume

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Mean Corpuscular Hemoglobin

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Mean Corpuscular Hemoglobin Concentration

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Red Blood Cell Distribution Width - Coefficient of Variation

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Red Blood Cell Distribution Width - Standard Deviation

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Hematocrit

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Nucleated red blood cell (NRBC) number

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Nucleated red blood cell percentage

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Platelet count

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Mean Platelet Volume

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Platelet Distribution Width

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Plateletcrit

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Immature Platelet Fraction

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Platelet-large cell ratio

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

  • Platelet-large cell count

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

    Within 8 hours of sample collection

Secondary Outcomes (48)

  • High fluorescent Cell number

    Within 8 hours of sample collection

  • High fluorescent Cell percentage

    Within 8 hours of sample collection

  • Optical Red Blood Cell count

    Within 8 hours of sample collection

  • Optical Platelet count

    Within 8 hours of sample collection

  • Platelet count - Impedance

    Within 8 hours of sample collection

  • +43 more secondary outcomes

Study Arms (1)

Healthy CALIPER Participants

Healthy community children and adolescents recruited through the CALIPER initiative as well as healthy children and adolescents recruited from outpatient clinics at the Hospital for Sick Children through the CALIPER initiative. Blood samples from these participants will be tested on the Mindray BC-6800Plus device to measure hematology parameters and establish reference intervals.

Diagnostic Test: Hematology Parameters

Interventions

Hematology ParametersDIAGNOSTIC_TEST

Measurement of hematology parameters on BC-6800Plus

Healthy CALIPER Participants

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy community children and adolescents as well as healthy children and adolescents recruited from outpatient clinics at the Hospital for Sick Children.

You may qualify if:

  • \<19 years

You may not qualify if:

  • History of chronic illness
  • Use of prescription medications within 2 weeks of collection
  • Acute illness within 7 days of collection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh whole blood specimens will be collected in K2EDTA tubes.

Study Officials

  • Khosrow Khosrow, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinical Biochemistry

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 17, 2021

Study Start

July 12, 2021

Primary Completion

January 28, 2022

Study Completion

February 11, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Summary collated and anonymized data for each test available on the BC-6800Plus platform will be presented in the form of: * Scatter plots of anonymized test results plotted by age and colour-coded by sex. * Tables of established reference intervals, partitioned by age, sex, and ethnicity, if applicable. To ensure that the knowledge gained from this study will be disseminated and available to all pediatric healthcare centres, laboratories, and pediatrician offices, our knowledge translation strategies include: * Submission of data for publication to a peer-reviewed journal. * Full data will be made available electronically via an online secure database on the CALIPER website and mobile app to facilitate access for the pediatric healthcare community internationally.

Locations

CA(1)