Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-01 @ 9:55 PM
Study NCT ID:
NCT04490759
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QStat Pilot Reference Range Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reference range intervals for measurement of Clot Time (CT) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.'}, {'measure': 'Reference range intervals for measurement of Clot Stiffness (CS) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.'}, {'measure': 'Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.'}, {'measure': 'Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.'}, {'measure': 'Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coagulation Disorder']}, 'descriptionModule': {'briefSummary': 'The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.', 'detailedDescription': 'This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and \\>50 years). The racial and ethnic profiles will be representative of the populations at the site.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is 18 years or older\n* Subject is willing to participate and has signed a consent form\n* Subject's laboratory coagulation test results at screening are within each test's normal reference range.\n\nExclusion Criteria:\n\n* Subject is younger than 18 years\n* Subject has a history of a coagulation disorder\n* Subject is pregnant or lactating\n* Subject is currently taking medications known to alter coagulation\n* Subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening\n* Subject had a blood transfusion or surgery within the last month\n* Drug abuse\n* Excessive alcohol consumption\n* Subject is unable to provide written informed consent\n* Subject is incarcerated at the time of the study\n* Subject previously participated in this study"}, 'identificationModule': {'nctId': 'NCT04490759', 'briefTitle': 'QStat Pilot Reference Range Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'HemoSonics LLC'}, 'officialTitle': 'Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge', 'orgStudyIdInfo': {'id': 'HEMCS-020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Blood samples from healthy volunteers analyzed on the Quantra System', 'interventionNames': ['Diagnostic Test: Quantra System']}], 'interventions': [{'name': 'Quantra System', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['QStat Cartridge'], 'description': 'Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'M3 Wake Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HemoSonics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}