Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-04-16 @ 6:48 PM
Study NCT ID:
NCT02754492
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Trima Version 7.0 Platelets in 100% Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Heather.Pidcoke@terumobct.com', 'phone': '(303) 231-4805', 'title': 'Heather Pidcoke, MD, PhD', 'organization': 'Terumo BCT, Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor retains the right to review and comment on any public disclosure of study results. If no response is received within 30 days, the Principal Investigator may presume that the submission for publication may proceed without delay. If the Sponsor asks to defer publication, Study Site shall not publish, or otherwise disclose to any third party, any of the information contained in the publication or presentation until such time as permission is granted from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.', 'description': 'Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Double Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Triple Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 6, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Unassigned', 'description': 'Subject and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 12, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Citrate Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection Site Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'OG001', 'title': 'Double Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'OG002', 'title': 'Triple Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}], 'classes': [{'categories': [{'title': 'Success (N)', 'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}, {'title': 'Failure (N)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Simple Sample Proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.989', 'ciLowerLimit': '0.950', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0107', 'groupDescription': 'Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "A procedure is a success if the subject's platelet product has a residual WBC count of \\< 5.0 × 10\\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%."}, {'groupIds': ['OG001'], 'paramType': 'Simple Sample Proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.968', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0', 'estimateComment': 'When estimated proportion is 100%, standard error of the mean is estimated as 0.', 'groupDescription': 'Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "A procedure is a success if the subject's platelet product has a residual WBC count of \\< 8.0 × 10\\^6 for the double platelet product group, or \\< 5.0 × 10\\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%."}, {'groupIds': ['OG002'], 'paramType': 'Simple Sample Proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.968', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0', 'estimateComment': 'When estimated proportion is 100%, standard error of the mean is estimated as 0.', 'groupDescription': 'Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "A procedure is a success if the subject's platelet product has a residual WBC count of \\< 12.0 × 10\\^6 for the triple platelet product group, or \\< 5.0 × 10\\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 48 hours of end of donation', 'description': 'The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level \\< 5.0 × 10\\^6; doubles = residual WBC level \\< 8.0 × 10\\^6 or \\< 5.0 × 10\\^6 for each transfusable unit; and triples = residual WBC level \\< 12.0 × 10\\^6 or \\< 5.0 × 10\\^6 for each transfusable unit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Platelet Units Containing an Acceptable Platelet Yield', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'OG001', 'title': 'Double Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'OG002', 'title': 'Triple Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}], 'classes': [{'categories': [{'title': 'Success (N)', 'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}, {'title': 'Failure (N)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Simple Sample Proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.989', 'ciLowerLimit': '0.950', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0107', 'groupDescription': 'Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%."}, {'groupIds': ['OG001'], 'paramType': 'Simple Sample Proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.968', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0', 'estimateComment': 'When estimated proportion is 100%, standard error of the mean is estimated as 0.', 'groupDescription': 'Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%."}, {'groupIds': ['OG002'], 'paramType': 'Simple Sample Proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.968', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0', 'estimateComment': 'When estimated proportion is 100%, standard error of the mean is estimated as 0.', 'groupDescription': 'Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 48 hours of end of donation', 'description': 'The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10\\^11 for singles, platelet yield ≥ 6.2 × 10\\^11 for doubles, and platelet yield ≥ 9.3 × 10\\^11 for triples.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'FG001', 'title': 'Double Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'FG002', 'title': 'Triple Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'FG003', 'title': 'Unassigned', 'description': 'Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Equipment malfuntion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Venous access issues not resulting in AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A participant was considered "enrolled" upon signing the informed consent form.', 'preAssignmentDetails': '334 participants consented/enrolled: 19 screen-failed; 5 never started procedure = 24 participants excluded from Safety Analysis.\n\n310 participants = Safety Analysis set (31 participants excluded from the full analysis set: 23 of these participants were "unassigned" to an Arm, 8 participants were assigned to an Arm)\n\n279 = Full Analysis set'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '310', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'BG001', 'title': 'Double Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'BG002', 'title': 'Triple Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections\n\nTrima Accel System with Version 7.0 Software: Platelet Apheresis Procedure'}, {'id': 'BG003', 'title': 'Unassigned', 'description': 'Subject and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age ≥ 18 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '310', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '168', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '261', 'groupId': 'BG004'}]}]}, {'title': 'No Response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '310', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '4.06', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '3.88', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '3.80', 'groupId': 'BG002'}, {'value': '69.1', 'spread': '2.92', 'groupId': 'BG003'}, {'value': '68.5', 'spread': '3.87', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '187.18', 'spread': '41.653', 'groupId': 'BG000'}, {'value': '202.00', 'spread': '44.835', 'groupId': 'BG001'}, {'value': '232.55', 'spread': '48.648', 'groupId': 'BG002'}, {'value': '196.00', 'spread': '39.852', 'groupId': 'BG003'}, {'value': '206.28', 'spread': '48.206', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Set = Includes all Subjects that had an apheresis procedure started.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-19', 'size': 428949, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-08-24T13:05', 'hasProtocol': True}, {'date': '2017-05-17', 'size': 327097, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-08-24T13:06', 'hasProtocol': False}, {'date': '2016-02-22', 'size': 164705, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-08-24T13:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2016-04-26', 'resultsFirstSubmitDate': '2018-02-08', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-27', 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level', 'timeFrame': 'Within 48 hours of end of donation', 'description': 'The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level \\< 5.0 × 10\\^6; doubles = residual WBC level \\< 8.0 × 10\\^6 or \\< 5.0 × 10\\^6 for each transfusable unit; and triples = residual WBC level \\< 12.0 × 10\\^6 or \\< 5.0 × 10\\^6 for each transfusable unit.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Platelet Units Containing an Acceptable Platelet Yield', 'timeFrame': 'Within 48 hours of end of donation', 'description': 'The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10\\^11 for singles, platelet yield ≥ 6.2 × 10\\^11 for doubles, and platelet yield ≥ 9.3 × 10\\^11 for triples.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in 100% plasma meet the FDA requirements for leukoreduction (\\< 5.0 × 10\\^6 residual white blood cells \\[WBC\\] per transfusable unit).', 'detailedDescription': 'The study is designed to evaluate changes to the Trima Accel software to ensure the modified software meets the FDA acceptance criteria for leukoreduction and platelet yield. The operating range for the system flow rates, anticoagulant ratios, storage conditions, and centrifugal forces are the same as the currently cleared Trima Accel system. There are no changes to the environment or storage conditions for platelets, therefore, no in vitro or in vivo platelet quality data will be collected.\n\nThis is a prospective, open-label, multi-center controlled study to evaluate the leukoreduction of platelets stored in 100% plasma collected on the Trima Accel system Version 7.0 software enhancement. Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 single, 93 double and 93 triple platelet product evaluable data points. Evaluable is defined as a completed platelet product that does not meet any of the protocol analysis exclusion criteria.\n\nPlateletpheresis will be per site standard practice and per applicable FDA guidelines such as the FDA Collection of Platelets by Automated Methods, December 2007 Guidance for Industry and Pre-storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion, September 2012.\n\nStudy participation will be up to 30 days and will consist of 1 to 2 visits. Screening may be done within 30 days before the apheresis procedure or combined as a single visit, which includes screening and the apheresis procedure all in 1 day.\n\nThe entire study should be completed in approximately 16 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older.\n* Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with plasma collection on the Trima Accel system. These criteria are based on FDA guidance and the American Association of Blood Banks (AABB) standards. Note: subjects who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused.\n* Has given written informed consent.\n\nExclusion Criteria:\n\n* Has previously donated an evaluable platelet product in this study (CTS 5060).'}, 'identificationModule': {'nctId': 'NCT02754492', 'briefTitle': 'Evaluation of Trima Version 7.0 Platelets in 100% Plasma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Terumo BCT'}, 'officialTitle': 'Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in 100% Plasma', 'orgStudyIdInfo': {'id': 'CTS-5060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.', 'interventionNames': ['Device: Trima Accel System with Version 7.0 Software']}, {'type': 'EXPERIMENTAL', 'label': 'Double Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.', 'interventionNames': ['Device: Trima Accel System with Version 7.0 Software']}, {'type': 'EXPERIMENTAL', 'label': 'Triple Platelet Product', 'description': 'Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections', 'interventionNames': ['Device: Trima Accel System with Version 7.0 Software']}], 'interventions': [{'name': 'Trima Accel System with Version 7.0 Software', 'type': 'DEVICE', 'description': 'Platelet Apheresis Procedure', 'armGroupLabels': ['Double Platelet Product', 'Single Platelet Product', 'Triple Platelet Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92102', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Blood Bank', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Bonfils Blood Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '46208', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Blood Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55114', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Memorial Blood Centers', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64111-2390', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Community Blood Center of Greater Kansas', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hoxworth Blood Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '53233', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Blood Center of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Heather Pidcoke, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Terumo BCT, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terumo BCT', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}