Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT02205827
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2014-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variability in whole blood clotting time measurement', 'timeFrame': '1 day', 'description': 'Assessment of variability in whole blood clotting time measurements in human blood collected from volunteers in across five technicians'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['whole blood clotting time'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.', 'detailedDescription': 'No investigational product was administered to any subject in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed and dated, written informed consent (Institutional Review Board \\[IRB\\]-approved informed consent form \\[ICF\\]).\n2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)\n\nExclusion Criteria:\n\n1. Healthy subjects who do not conform to the above inclusion criteria.\n2. Healthy subjects who cannot communicate reliably with the Investigator.\n3. History of major bleeding or major trauma within the past 6 months\n4. Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).\n5. Significant infection or known inflammatory process within 2 weeks of screening.\n6. Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.\n7. Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin \\[ASA\\]) with a direct effect on hemostasis within 7 days of testing\n8. Unwillingness or inability to comply with procedures required in this protocol.\n9. Subjects who are concurrently enrolled in any other clinical study.'}, 'identificationModule': {'nctId': 'NCT02205827', 'briefTitle': 'A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements', 'organization': {'class': 'INDUSTRY', 'fullName': 'AMAG Pharmaceuticals, Inc.'}, 'officialTitle': 'A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements', 'orgStudyIdInfo': {'id': 'PER977-01-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Single-arm', 'description': 'healthy volunteers', 'interventionNames': ['Other: Single-arm']}], 'interventions': [{'name': 'Single-arm', 'type': 'OTHER', 'otherNames': ['Whole Blood Clotting Time assessment'], 'description': 'collection of blood for assessment of whole blood clotting time', 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Quintiles Phase I Services, LLC', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'James Costin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}