Apheresis Related HypotensionNCT06122935
Evaluation of the Aurora Xi New Nomogram Software 2.0
A study testing Aurora Xi New Nomogram Software 2.0 and Aurora Xi Currently Approved Software 1.3 in people with Apheresis Related Hypotension, run by Fenwal, Inc. at 3 sites in United States.
Trial summary
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apheresis Related Hypotension
- What is being tested?
- Aurora Xi New Nomogram Software 2.0 and Aurora Xi Currently Approved Software 1.3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,735 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Nov 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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- Subjects withdrawn by a qualified healthcare provider due to safety concerns.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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
BioLife Plasma Services
American Fork, Utah, 84003
BioLife Plasma Services
Lakeland, Florida, 33813
BioLife Plasma Services
West Des Moines, Iowa, 50266
About this study
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.
Read the 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.
- Conditions
- Apheresis Related Hypotension
- Being tested
- Aurora Xi New Nomogram Software 2.0, Aurora Xi Currently Approved Software 1.3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurora Xi New Nomogram Software 2.0Device
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 1.3Device
Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System Receives: Device: Aurora Xi New Nomogram Software 2.0 |
| Control Group | Active comparator | Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System Receives: Device: Aurora Xi Currently Approved Software 1.3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From venipuncture through 72 hours post-donation.
Secondary outcomes (6)
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).
Measured: From Venipuncture through 72 Hours post-donation.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From venipuncture through end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start27 Nov 2023
- Primary completion19 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Apheresis Related HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6,735 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenwal, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carrie Pineda, Study director, Fresenius Kabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122935
- Sponsor's protocol ID
- PAND-004-CMD
- Status last verified
- Oct 2025
- First submitted
- 3 Nov 2023
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Aurora Xi New Nomogram Software 2.0
- ClinicalTrials.gov ID
- NCT06122935
- Acronym / sponsor ID
- PAND-004-CMD
- Conditions
- Apheresis Related Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,735 participants (actual)
- Lead sponsor
- Fenwal, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Aurora Xi New Nomogram Software 2.0Plasma collection using a new plasma collection volume nomogram (software version 2.0) for the Aurora Xi Plasmapheresis System |
| Control Group | Active comparator | Device: Aurora Xi Currently Approved Software 1.3Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aurora Xi New Nomogram Software 2.0Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor. | Device | Test Group |
| Aurora Xi Currently Approved Software 1.3Plasma collection using the currently marketed Optimized Nomogram (software version 1.3) for the Aurora Xi Plasmapheresis System | Device | Control Group |
Primary outcome
Rate of Significant Hypotensive Adverse Events
Time frame: 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.
6 secondary outcomes
Rate of Severe Hypotensive Adverse Events Relative to Donor Type
Time frame: From Venipuncture through 72 Hours post-donation.
Rate of Severe Hypotensive Adverse Events Relative to Sex
Time frame: From venipuncture through 72 hours post-donation.
Rate of Severe Hypotensive Adverse Events Relative to Age
Time frame: From venipuncture through 72 hours post-donation.
Rate of Severe Hypotensive Adverse Events Relative to Weight
Time frame: From venipuncture through 72 hours post-donation.
Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6)
Time frame: From venipuncture through 72 hours post-donation.
Time From Start of Plasmapheresis Procedure to the First SHAE
Time frame: From venipuncture through end of the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Pineda study director
Fresenius Kabi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aurora Xi New Nomogram Software 2.0 and Aurora Xi Currently Approved Software 1.3 in people with Apheresis Related Hypotension, run by Fenwal, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Significant Hypotensive Adverse Events (time frame: From venipuncture through 72 hours post-donation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.