Evaluation of the Aurora Xi New Nomogram Software 2.0

Study Overview
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Brief Summary
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A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.

Detailed Description
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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.

Official Title
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Evaluation of the Aurora Xi New Nomogram Software 2.0

Conditions
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Apheresis Related Hypotension

Intervention / Treatment
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* Device: Aurora Xi New Nomogram Software 2.0
* Device: Aurora Xi Currently Approved Software 1.3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Exclusion Criteria: Subjects not able or unwilling to give consent to participate. Subjects withdrawn by a qualified healthcare provider due to safety concerns. Subjects who are employed by the clinical site or Sponsor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System | Device: Aurora Xi New Nomogram Software 2.0<br>* Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.<br>|
| Active Comparator: Control Group<br>Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System | Device: Aurora Xi Currently Approved Software 1.3<br>* Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Significant Hypotensive Adverse Events | 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. | Up to approximately 9 months, depending on time of enrollment into the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Severe Hypotensive Adverse Events Relative to Donor Type | To determine if the incidence rate of SHAEs per donor status (first-time or repeat donor) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm). | Up to approximately 9 months, depending on time of enrollment into the trial. | 
| Rate of Severe Hypotensive Adverse Events Relative to Sex | 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). | Up to approximately 9 months, depending on time of enrollment into the trial. | 
| Rate of Severe Hypotensive Adverse Events Relative to Age | 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). | Up to approximately 9 months, depending on time of enrollment into the trial. | 
| Rate of Severe Hypotensive Adverse Events Relative to Weight | 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). | Up to approximately 9 months, depending on time of enrollment into the trial. | 
| Rate of hypotensive severe/injury adverse events (IQPP DAE Classification 1.5 or 1.6) | 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). | Up to approximately 9 months, depending on time of enrollment into the trial. | 
| Time from start of plasmapheresis procedure to the first SHAE | 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). | Up to approximately 9 months, depending on time of enrollment into the trial. |