Status:
COMPLETED
DxH520 Pediatric Reference Interval Verification
Lead Sponsor:
Beckman Coulter, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
1-21 years
Brief Summary
Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.
Detailed Description
Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published referenc...
Eligibility Criteria
Inclusion
- All subject genders, race and ethnicity will be included in the study. Pediatric samples will be targeted for this study within the specified age ranges.
- Specimens should be from apparently healthy individuals.
- Samples from inpatient and ED visits maybe included if they are confirmed to be the final CBC before discharge and the patient had a non-hematological diagnosis
Exclusion
- Samples originating from a hematology/oncology clinic (both inpatient and outpatient)
- Samples originating from a patient with a hematological disorder or diagnosis
- Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge
Key Trial Info
Start Date :
June 19 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT03243266
Start Date
June 19 2017
End Date
May 2 2018
Last Update
July 13 2018
Active Locations (2)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T2N 2T9
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8