Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-01 @ 4:54 PM
Study NCT ID:
NCT03243266
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2017-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DxH520 Pediatric Reference Interval Verification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Reference Interval Verification of Hematology CBC/Diff parameters', 'timeFrame': '1 day', 'description': 'Verify Reference Intervals of Hematology CBC/Diff parameters in pediatric age groups. The blood cell count test parameters to be verified are:\n\nWhite Blood Cells (x10\\^3/µL), Red Blood Cells (x10\\^6/µL), Hemoglobin (g/dL), Hematocrit %, Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/dL), Mean Corpuscular Volume (fL), Red Cell Distribution Width-CV (%) Red cell Distribution Width-SD (fL), Platelets (x10\\^3/µL), Mean Platelet Volume (fL), Neutrophil %, Neutrophil Count (x10\\^3/µL), Lymphocyte %, Lymphocyte Count (x10\\^3/µL), Monocyte %, Monocyte Count (x10\\^3/µL), Eosinophil %, Eosinophil Count (x10\\^3/µL), Basophil %, Basophil Count (x10\\^3/µL). Study results will be analyzed following CLSI guideline EP28-A3c.'}]}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:\n\n1. Neonate: 0 to 30 days\n2. Infant: \\> 30 days to 2 years\n3. Child: 3 years to 12 years\n4. Adolescent: 13 years to 21 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Minute', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric specimens from apparently healthy children', 'genderDescription': 'Male, Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Specimens should be from apparently healthy individuals.\n* 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\n\nExclusion Criteria:\n\n* Samples originating from a hematology/oncology clinic (both inpatient and outpatient)\n* Samples originating from a patient with a hematological disorder or diagnosis\n* Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge'}, 'identificationModule': {'nctId': 'NCT03243266', 'briefTitle': 'DxH520 Pediatric Reference Interval Verification', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beckman Coulter, Inc.'}, 'officialTitle': 'DxH520 Pediatric Reference Interval Verification', 'orgStudyIdInfo': {'id': 'B90590'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CBC/Diff Reference Interval', 'description': 'Hematology routine diagnostic test', 'interventionNames': ['Diagnostic Test: CBC/Diff Reference Interval']}], 'interventions': [{'name': 'CBC/Diff Reference Interval', 'type': 'DIAGNOSTIC_TEST', 'description': 'Results will not be used to manage patients', 'armGroupLabels': ['CBC/Diff Reference Interval']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Khosrow Adeli, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}, {'name': 'Meer-Taher Shabani-Rad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Alberta Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beckman Coulter, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}