Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
6735 participants
INTERVENTIONAL
2023-11-27
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Test Group
Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System
Aurora 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.
Control Group
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Aurora Xi Currently Approved Software 1.3
Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
Interventions
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Aurora 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.
Aurora Xi Currently Approved Software 1.3
Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects withdrawn by a qualified healthcare provider due to safety concerns.
* Subjects who are employed by the clinical site or Sponsor.
18 Years
ALL
Yes
Sponsors
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Fenwal, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carrie Pineda
Role: STUDY_DIRECTOR
Fresenius Kabi
Locations
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BioLife Plasma Services
Lakeland, Florida, United States
BioLife Plasma Services
West Des Moines, Iowa, United States
BioLife Plasma Services
American Fork, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PAND-004-CMD
Identifier Type: -
Identifier Source: org_study_id