Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT06122935
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2023-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the Aurora Xi New Nomogram Software 2.0
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jason.friedmann@fresenius-kabi.com', 'phone': '847-550-2365', 'title': 'Jason Friedmann', 'organization': 'Fresenius Kabi'}, 'certainAgreement': {'otherDetails': 'The protocol, procedures, and data pertaining to this study will be treated as confidential information. Publication of data and/or information derived from these studies must be done with the prior review and approval of the Sponsor. Scientific personnel may share authorship with investigators on abstracts, oral presentations and manuscripts. The first author will be the person assuming primary responsibility for the abstract or manuscript.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from venipuncture through 72 hours post-donation. The subject had up to 2 weeks post-donation to self-report any AEs that occur through 72 hours post-donation. Adverse events were collected for the duration of the study (4 months and 23 days).', 'description': 'For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events.\n\nAdverse event data were monitored and assessed per procedure, rather than at the participant level.', 'eventGroups': [{'id': 'EG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.', 'otherNumAtRisk': 26351, 'deathsNumAtRisk': 26351, 'otherNumAffected': 338, 'seriousNumAtRisk': 26351, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System', 'otherNumAtRisk': 26117, 'deathsNumAtRisk': 26117, 'otherNumAffected': 309, 'seriousNumAtRisk': 26117, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'IQPP 1.1 Hypotensive, Prefaint, No LOC (Minor)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 221, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 201, 'numAffected': 201}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 1.2 Hypotensive, Prefaint, No LOC (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 1.3 Hypotensive, LOC (brief)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 1.4 Hypotensive, LOC (prolonged)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 1.5 Hypotensive, Severe (With or Without LOC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 1.6 Hypotensive, Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 3. Local Injury Related to Phlebotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 4. Citrate Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 7.1 Allergic, Local', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 8. Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IQPP 9. Other', 'notes': 'Chest pressure/pain/tightness; unknown etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Significant Hypotensive Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3363', 'groupId': 'OG000'}, {'value': '3372', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '26351', 'groupId': 'OG000'}, {'value': '26117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'The primary objective of this study is to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi New Nomogram algorithm is less than double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm.', 'unitOfMeasure': 'Procedure with a SHAE', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Severe Hypotensive Adverse Events Relative to Donor Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1043', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1043', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Venipuncture through 72 Hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs per donor status (first-time donor) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).', 'unitOfMeasure': 'Number of Participants with a SHAE', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Severe Hypotensive Adverse Events Relative to Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1529', 'groupId': 'OG000'}, {'value': '1532', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '11377', 'groupId': 'OG000'}, {'value': '11372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs for female donors observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).', 'unitOfMeasure': 'Procedure with a SHAE', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Severe Hypotensive Adverse Events Relative to Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '1292', 'groupId': 'OG000'}, {'value': '1452', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs for donors ≤20 years of age observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).', 'unitOfMeasure': 'Procedure with a SHAE', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Severe Hypotensive Adverse Events Relative to Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs for donors weighting ≤124 lbs observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).', 'calculatePct': False, 'unitOfMeasure': 'Procedure with a SHAE', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3363', 'groupId': 'OG000'}, {'value': '3372', 'groupId': 'OG001'}]}, {'units': 'Procedures', 'counts': [{'value': '26351', 'groupId': 'OG000'}, {'value': '26117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of hypotensive severe/injury adverse events (IQPP DAE Classification 1.5 or 1.6) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).', 'unitOfMeasure': 'Procedure with a SHAE', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Procedures', 'denomUnitsSelected': 'Procedures'}, {'type': 'SECONDARY', 'title': 'Time From Start of Plasmapheresis Procedure to the First SHAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'classes': [{'categories': [{'measurements': [{'value': '44.26', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '40.53', 'spread': '40.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From venipuncture through end of the procedure.', 'description': 'To determine if the time from start of plasmapheresis procedure to the first SHAE observed with the New Nomogram (Test arm) is non-inferior to the time observed with the Optimized Nomogram (Control arm).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Procedures in which a SHAE occurred.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '26351', 'numSubjects': '3363'}, {'groupId': 'FG001', 'numUnits': '26117', 'numSubjects': '3372'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '26351', 'numSubjects': '3363'}, {'groupId': 'FG001', 'numUnits': '26117', 'numSubjects': '3372'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Procedures', 'recruitmentDetails': 'A total of 6,735 subjects were enrolled in the study at 3 investigative sites and completed 52,468 Per Protocol procedures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3363', 'groupId': 'BG000'}, {'value': '3372', 'groupId': 'BG001'}, {'value': '6735', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System\n\nAurora Xi New Nomogram Software 2.0: Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System\n\nAurora Xi Currently Approved Software 1.3: Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '12.38', 'groupId': 'BG000'}, {'value': '36.5', 'spread': '12.53', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '12.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1521', 'groupId': 'BG000'}, {'value': '1526', 'groupId': 'BG001'}, {'value': '3047', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1842', 'groupId': 'BG000'}, {'value': '1846', 'groupId': 'BG001'}, {'value': '3688', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '630', 'groupId': 'BG000'}, {'value': '642', 'groupId': 'BG001'}, {'value': '1272', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2704', 'groupId': 'BG000'}, {'value': '2710', 'groupId': 'BG001'}, {'value': '5414', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '547', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2831', 'groupId': 'BG000'}, {'value': '2853', 'groupId': 'BG001'}, {'value': '5684', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3363', 'groupId': 'BG000'}, {'value': '3372', 'groupId': 'BG001'}, {'value': '6735', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-16', 'size': 546925, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-03T14:54', 'hasProtocol': True}, {'date': '2023-10-02', 'size': 1898814, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-03T14:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6735}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2023-11-03', 'resultsFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-29', 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Significant Hypotensive Adverse Events', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'The primary objective of this study is to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi New Nomogram algorithm is less than double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm.'}], 'secondaryOutcomes': [{'measure': 'Rate of Severe Hypotensive Adverse Events Relative to Donor Type', 'timeFrame': 'From Venipuncture through 72 Hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs per donor status (first-time donor) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).'}, {'measure': 'Rate of Severe Hypotensive Adverse Events Relative to Sex', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs for female donors observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).'}, {'measure': 'Rate of Severe Hypotensive Adverse Events Relative to Age', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs for donors ≤20 years of age observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).'}, {'measure': 'Rate of Severe Hypotensive Adverse Events Relative to Weight', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of SHAEs for donors weighting ≤124 lbs observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).'}, {'measure': 'Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6)', 'timeFrame': 'From venipuncture through 72 hours post-donation.', 'description': 'To determine if the incidence rate of hypotensive severe/injury adverse events (IQPP DAE Classification 1.5 or 1.6) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).'}, {'measure': 'Time From Start of Plasmapheresis Procedure to the First SHAE', 'timeFrame': 'From venipuncture through end of the procedure.', 'description': 'To determine if the time from start of plasmapheresis procedure to the first SHAE observed with the New Nomogram (Test arm) is non-inferior to the time observed with the Optimized Nomogram (Control arm).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Apheresis Related Hypotension']}, 'descriptionModule': {'briefSummary': 'A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.', 'detailedDescription': 'A controlled, prospective, randomized, multicenter, IDE clinical trial to evaluate the safety and effectiveness of a new plasma collection volume nomogram on the Aurora Xi Plasmapheresis System (test arm) as compared to the currently marketed Optimized Nomogram on the Aurora Xi Plasmapheresis System (control arm). The new plasma collection volume nomogram will provide a more individualized approach to determining the volume of plasma collected from each donor. The trial will be conducted at a minimum of 3 plasma collection centers. Subjects will be randomized into the test and control arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects must meet current safety guidelines for plasma donation as set forth by the FDA as well as those in the standard operating procedures established by the participating institution.\n* Enrolled subjects who do not meet inclusion criteria at a later donation attempt are eligible to remain in the clinical trial and to subsequently donate plasma once they meet eligibility criteria again.\n\nExclusion Criteria:\n\n* Subjects not able or unwilling to give consent to participate.\n* Subjects withdrawn by a qualified healthcare provider due to safety concerns.\n* Subjects who are employed by the clinical site or Sponsor.'}, 'identificationModule': {'nctId': 'NCT06122935', 'briefTitle': 'Evaluation of the Aurora Xi New Nomogram Software 2.0', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fenwal, Inc.'}, 'officialTitle': 'Evaluation of the Aurora Xi New Nomogram Software 2.0', 'orgStudyIdInfo': {'id': 'PAND-004-CMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System', 'interventionNames': ['Device: Aurora Xi New Nomogram Software 2.0']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System', 'interventionNames': ['Device: Aurora Xi Currently Approved Software 1.3']}], 'interventions': [{'name': 'Aurora Xi New Nomogram Software 2.0', 'type': 'DEVICE', 'description': 'Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.', 'armGroupLabels': ['Test Group']}, {'name': 'Aurora Xi Currently Approved Software 1.3', 'type': 'DEVICE', 'description': 'Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33813', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'BioLife Plasma Services', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'BioLife Plasma Services', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '84003', 'city': 'American Fork', 'state': 'Utah', 'country': 'United States', 'facility': 'BioLife Plasma Services', 'geoPoint': {'lat': 40.3769, 'lon': -111.79576}}], 'overallOfficials': [{'name': 'Carrie Pineda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fresenius Kabi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fenwal, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}