Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-07 @ 2:00 AM
Study NCT ID:
NCT03338660
Status:
WITHDRAWN
Last Update Posted:
2019-05-29
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Function With Various Storage Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'the assesor of platelet function and the PI will be blinded to group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'crossover study of various storage infusions techniques with each subject receiving various fluids aliquots.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to begin study due to funding. PI has left organization.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in platelet function', 'timeFrame': '1 hour post-transfusion', 'description': 'Frozen platelets will result in improvement in platelet function after transfusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet Dysfunction Due to Drugs']}, 'descriptionModule': {'briefSummary': 'Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology.', 'detailedDescription': 'Subjects will undergo administration of antiplatelet drugs and then will receive platelets stored in a variety of methods. Platelet function will be measured serially.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal subjects\n\nExclusion Criteria:\n\n* Pre existing antiplatelet drugs'}, 'identificationModule': {'nctId': 'NCT03338660', 'briefTitle': 'Platelet Function With Various Storage Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'The Impact of Various Storage Techniques on Platelet Function', 'orgStudyIdInfo': {'id': '16-XXXX-SIUHN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control (Placebo)', 'description': 'Subjects will receive infusion of placebo (saline).', 'interventionNames': ['Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet storage routine', 'description': 'Subjects will receive infusion of platelets stored by routine method.', 'interventionNames': ['Biological: Infusion of Platelets']}, {'type': 'EXPERIMENTAL', 'label': 'Platelet storage experimental', 'description': 'Subjects will receive infusion of platelets stored by a novel methodology.', 'interventionNames': ['Biological: Infusion of Platelets']}], 'interventions': [{'name': 'Infusion of Platelets', 'type': 'BIOLOGICAL', 'otherNames': ['Novel Storage Methodology'], 'description': 'Platelets will be stored using novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline).', 'armGroupLabels': ['Platelet storage experimental']}, {'name': 'Infusion of Platelets', 'type': 'BIOLOGICAL', 'otherNames': ['Routine Storage Method'], 'description': 'Platelets will be stored using the routine platelet storage method. Subjects will receive infusion of platelets stored by routine storage method.', 'armGroupLabels': ['Platelet storage routine']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['Placebo (Saline)'], 'description': 'Subjects will receive infusion placebo (saline).', 'armGroupLabels': ['Control (Placebo)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}