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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System |
|
| Control Group | Active Comparator | Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aurora Xi New Nomogram Software 2.0 | Device | Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor. |
| 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. | From venipuncture through 72 hours post-donation. |
| 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 donor) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm). | From Venipuncture through 72 Hours post-donation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Pineda | Fresenius Kabi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioLife Plasma Services | Lakeland | Florida | 33813 | United States | ||
| BioLife Plasma Services |
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A total of 6,735 subjects were enrolled in the study at 3 investigative sites and completed 52,468 Per Protocol procedures.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Procedure with a SHAE | From venipuncture through 72 hours post-donation. | Procedures | Procedures |
|
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).
For the purposes of this study, all adverse events were defined and categorized using IQPP Standard for Recording Donor Adverse Events.
Adverse event data were monitored and assessed per procedure, rather than at the participant level.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IQPP 1.1 Hypotensive, Prefaint, No LOC (Minor) | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Friedmann | Fresenius Kabi | 847-550-2365 | jason.friedmann@fresenius-kabi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2024 | Jun 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2023 | Jun 3, 2025 | SAP_001.pdf |
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| Aurora Xi Currently Approved Software 1.3 | Device | Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System |
|
| 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). |
| From venipuncture through 72 hours post-donation. |
| 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). | From venipuncture through 72 hours post-donation. |
| 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). | From venipuncture through 72 hours post-donation. |
| 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). | From venipuncture through 72 hours post-donation. |
| 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). | From venipuncture through end of the procedure. |
| West Des Moines |
| Iowa |
| 50266 |
| United States |
| BioLife Plasma Services | American Fork | Utah | 84003 | United States |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
|
|
| Secondary | Rate of Severe Hypotensive Adverse Events Relative to Donor Type | 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). | Posted | Number | Number of Participants with a SHAE | From Venipuncture through 72 Hours post-donation. | Procedures | Procedures |
|
|
|
| Secondary | 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). | Posted | Number | Procedure with a SHAE | From venipuncture through 72 hours post-donation. | Procedures | Procedures |
|
|
|
| Secondary | 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). | Posted | Number | Procedure with a SHAE | From venipuncture through 72 hours post-donation. | Procedures | Procedures |
|
|
|
| Secondary | 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). | Posted | Number | Procedure with a SHAE | No | From venipuncture through 72 hours post-donation. | Procedures | Procedures |
|
|
|
| Secondary | 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). | Posted | Number | Procedure with a SHAE | From venipuncture through 72 hours post-donation. | Procedures | Procedures |
|
|
|
| Secondary | 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). | Procedures in which a SHAE occurred. | Posted | Mean | Standard Deviation | minutes | From venipuncture through end of the procedure. |
|
|
|
| 0 |
| 26,351 |
| 0 |
| 26,351 |
| 338 |
| 26,351 |
| EG001 | 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 | 0 | 26,117 | 0 | 26,117 | 309 | 26,117 |
| IQPP 1.2 Hypotensive, Prefaint, No LOC (Moderate) | Cardiac disorders | Systematic Assessment |
|
| IQPP 1.3 Hypotensive, LOC (brief) | Cardiac disorders | Systematic Assessment |
|
| IQPP 1.4 Hypotensive, LOC (prolonged) | Cardiac disorders | Systematic Assessment |
|
| IQPP 1.5 Hypotensive, Severe (With or Without LOC) | Cardiac disorders | Systematic Assessment |
|
| IQPP 1.6 Hypotensive, Injury | Cardiac disorders | Systematic Assessment |
|
| IQPP 3. Local Injury Related to Phlebotomy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| IQPP 4. Citrate Reaction | Blood and lymphatic system disorders | Systematic Assessment |
|
| IQPP 7.1 Allergic, Local | General disorders | Systematic Assessment |
|
| IQPP 8. Hyperventilation | General disorders | Systematic Assessment |
|
| IQPP 9. Other | General disorders | Systematic Assessment | Chest pressure/pain/tightness; unknown etiology |
|
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.