Apheresis Related Hypotension
Conditions
Brief summary
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.
Detailed description
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.
Interventions
DEVICEAurora 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.
DEVICEAurora Xi Currently Approved Software 1.3
Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
Sponsors
Fenwal, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 * Subjects withdrawn by a qualified healthcare provider due to safety concerns.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Significant Hypotensive Adverse Events | From venipuncture through 72 hours post-donation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Severe Hypotensive Adverse Events Relative to Sex | From venipuncture through 72 hours post-donation. | 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). |
| Rate of Severe Hypotensive Adverse Events Relative to Age | From venipuncture through 72 hours post-donation. | 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). |
| Rate of Severe Hypotensive Adverse Events Relative to Donor Type | From Venipuncture through 72 Hours post-donation. | 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). |
| Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6) | From venipuncture through 72 hours post-donation. | 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). |
| Time From Start of Plasmapheresis Procedure to the First SHAE | From venipuncture through end of the procedure. | 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). |
| Rate of Severe Hypotensive Adverse Events Relative to Weight | From venipuncture through 72 hours post-donation. | 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). |
Countries
United States
Participant flow
Recruitment details
A total of 6,735 subjects were enrolled in the study at 3 investigative sites and completed 52,468 Per Protocol procedures.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,363 |
| 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 | 3,372 |
| Total | 6,735 |
Baseline characteristics
| Characteristic | Test Group | Total | Control Group |
|---|---|---|---|
| Age, Customized | 36.9 years STANDARD_DEVIATION 12.38 | 36.7 years STANDARD_DEVIATION 12.46 | 36.5 years STANDARD_DEVIATION 12.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 630 Participants | 1272 Participants | 642 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2704 Participants | 5414 Participants | 2710 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 29 Participants | 49 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 28 Participants | 45 Participants | 17 Participants |
| Race (NIH/OMB) Asian | 46 Participants | 84 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 275 Participants | 547 Participants | 272 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 39 Participants | 74 Participants | 35 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 144 Participants | 301 Participants | 157 Participants |
| Race (NIH/OMB) White | 2831 Participants | 5684 Participants | 2853 Participants |
| Region of Enrollment United States | 3363 participants | 6735 participants | 3372 participants |
| Sex: Female, Male Female | 1521 Participants | 3047 Participants | 1526 Participants |
| Sex: Female, Male Male | 1842 Participants | 3688 Participants | 1846 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26,351 | 0 / 26,117 |
| other Total, other adverse events | 338 / 26,351 | 309 / 26,117 |
| serious Total, serious adverse events | 0 / 26,351 | 0 / 26,117 |
Outcome results
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.
Time frame: From venipuncture through 72 hours post-donation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Rate of Significant Hypotensive Adverse Events | 43 Procedure with a SHAE |
| Control Group | Rate of Significant Hypotensive Adverse Events | 42 Procedure with a SHAE |
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).
Time frame: From venipuncture through 72 hours post-donation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6) | 10 Procedure with a SHAE |
| Control Group | Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6) | 8 Procedure with a SHAE |
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).
Time frame: From venipuncture through 72 hours post-donation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Rate of Severe Hypotensive Adverse Events Relative to Age | 5 Procedure with a SHAE |
| Control Group | Rate of Severe Hypotensive Adverse Events Relative to Age | 5 Procedure with a SHAE |
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).
Time frame: From Venipuncture through 72 Hours post-donation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Rate of Severe Hypotensive Adverse Events Relative to Donor Type | 9 Number of Participants with a SHAE |
| Control Group | Rate of Severe Hypotensive Adverse Events Relative to Donor Type | 5 Number of Participants with a SHAE |
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).
Time frame: From venipuncture through 72 hours post-donation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Rate of Severe Hypotensive Adverse Events Relative to Sex | 31 Procedure with a SHAE |
| Control Group | Rate of Severe Hypotensive Adverse Events Relative to Sex | 29 Procedure with a SHAE |
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).
Time frame: From venipuncture through 72 hours post-donation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Rate of Severe Hypotensive Adverse Events Relative to Weight | 1 Procedure with a SHAE |
| Control Group | Rate of Severe Hypotensive Adverse Events Relative to Weight | 2 Procedure with a SHAE |
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).
Time frame: From venipuncture through end of the procedure.
Population: Procedures in which a SHAE occurred.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Time From Start of Plasmapheresis Procedure to the First SHAE | 44.26 minutes | Standard Deviation 10.22 |
| Control Group | Time From Start of Plasmapheresis Procedure to the First SHAE | 40.53 minutes | Standard Deviation 40.2 |