Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-09 @ 6:13 AM
Study NCT ID:
NCT05645133
Status:
TERMINATED
Last Update Posted:
2023-06-15
First Post:
2022-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QPlus Pediatric Reference Interval
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI relocated to another institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reference range interval for measurement of clot time (CT) parameter', 'timeFrame': 'Baseline, after access placement before any procedures', 'description': 'Reference range interval determined in this study will serve as the reference for CT results in this particular population'}, {'measure': 'Reference range interval for measurement of clot time (CTH) parameter', 'timeFrame': 'Baseline, after access placement before any procedures', 'description': 'Reference range interval determined in this study will serve as the reference for CTH results in this particular population'}, {'measure': 'Reference range interval for measurement of clot stiffness (CS) parameter', 'timeFrame': 'Baseline, after access placement before any procedures', 'description': 'Reference range interval determined in this study will serve as the reference for CS results in this particular population'}, {'measure': 'Reference range interval for measurement of Fibrinogen Contribution to clot stiffness (FCS) parameter', 'timeFrame': 'Baseline, after access placement before any procedures', 'description': 'Reference range interval determined in this study will serve as the reference for FCS results in this particular population'}, {'measure': 'Reference range interval for measurement of Platelet Contribution to clot stiffness (PCS) parameter', 'timeFrame': 'Baseline, after access placement before any procedures', 'description': 'Reference range interval determined in this study will serve as the reference for PCS results in this particular population'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['QPlus', 'Quantra', 'Pediatric', 'Reference Range'], 'conditions': ['Pediatric ALL', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.', 'detailedDescription': 'Single center observational study of the pediatric patient population (\\< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with normal coagulation function who have been scheduled to undergo a procedure and blood sampling access has been established. All genders, racial and ethnic profiles will be described.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<18yrs\n* Scheduled for procedure requiring anesthesia\n* Access to blood sampling\n* Consented\n\nExclusion Criteria:\n\n* \\>18yrs of age\n* pre-term babies\n* patients with know hematological disorders\n* Difficult to obtain blood sampling\n* Has received a blood product transfusion within the last 24hrs.\n* Legal guardian unwilling to consent'}, 'identificationModule': {'nctId': 'NCT05645133', 'briefTitle': 'QPlus Pediatric Reference Interval', 'organization': {'class': 'INDUSTRY', 'fullName': 'HemoSonics LLC'}, 'officialTitle': 'Evaluation of a Pediatric Reference Interval Using QPLUS System', 'orgStudyIdInfo': {'id': 'IIS-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diagnostic Test', 'type': 'DEVICE', 'otherNames': ['Point of Care test', 'Quantra'], 'description': 'Diagnostic device to monitor coagulation properties of a whole blood sample at the point of care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Nicklaus Childrens Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Christopher Tirotta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nicklaus Childrens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HemoSonics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}