Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT02207205
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2014-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
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': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture', 'timeFrame': 'single day sampling', 'description': 'Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple technicians'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture\n2. Determine the intra-subject variability in both procedures', 'detailedDescription': 'No investigational products were administered to any subjects.'}, '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 (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture.\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 drug (NSAID) or medications (including aspirin) 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': 'NCT02207205', 'briefTitle': 'Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.'}, 'officialTitle': 'A Study to Determine Variability in the Measurement of Whole Blood Clotting Time (WBCT) Between Blood Drawn From Indwelling Catheters and Direct Venipuncture', 'orgStudyIdInfo': {'id': 'PER977-01-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Catheter vs venipuncture blood samples', 'description': 'Evaluation of whether there is any difference in results of whole blood clotting time in blood samples drawn from an indwelling catheter versus direct venipuncture', 'interventionNames': ['Drug: Blood drawn from indwelling catheters versus direct venipuncture']}], 'interventions': [{'name': 'Blood drawn from indwelling catheters versus direct venipuncture', 'type': 'DRUG', 'description': 'Evaluation of the source of blood samples on whole blood clotting time', 'armGroupLabels': ['Catheter vs venipuncture blood samples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Clinical Research Unit', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Robert Noveck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}