Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT06415760
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2024-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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 for CSL for pregnant women in third trimester'}, {'measure': 'Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals for FCS for pregnant women in third trimester'}, {'measure': 'Reference range intervals for measurement of Platelet Contribution (PCS) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals for PCS for pregnant women in third trimester'}, {'measure': 'Reference range intervals for measurement of Clot Stiffness (CS) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals for CS for pregnant women in third trimester'}, {'measure': 'Reference range intervals for measurement of Clot Time (CT) parameter', 'timeFrame': 'Baseline, determined from a single blood draw', 'description': 'Reference range intervals for CT for pregnant women in third trimester'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Quantra', 'Viscoelastic testing', 'Coagulation'], 'conditions': ['Obstetric Hemostasis', 'Coagulation']}, 'descriptionModule': {'briefSummary': 'This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy', 'detailedDescription': 'During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult pregnant women 18 years of age or older in their third trimester of pregnancy with no prenatal risk factors and an uncomplicated pregnancy.', 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is female, age 18 to 45 years old.\n* Subject is pregnant with a single fetus and duration of pregnancy is \\>28weeks\n* Subject is willing to participate and has provided informed consent.\n\nExclusion Criteria:\n\n* Subject has a history of a coagulation disorder (including excessive bleeding, thrombosis, VWD, or any factor deficiencies).\n* Subject has taken medications known to alter coagulation during pregnancy including heparin, warfarin/Coumadin®, antiplatelet drugs including Plavix® or aspirin at a dose greater than 81 mg/day, Xarelto® or Eliquis®, or other anticoagulants.\n* Subject has experienced one or more complications during pregnancy such as gestational diabetes, high blood pressure, pre-eclampsia or eclampsia, hypovolemia or pre-term labor.\n* Subject had a blood transfusion during pregnancy.\n* Subject has a history of smoking/vaping during pregnancy'}, 'identificationModule': {'nctId': 'NCT06415760', 'briefTitle': 'Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'HemoSonics LLC'}, 'officialTitle': 'Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients', 'orgStudyIdInfo': {'id': 'HEMCS-047'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obstetric Patients', 'description': 'Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy.', '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': ['Obstetric Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unified Womens Clinical Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unified Womens Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HemoSonics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}