Evaluation of the Aurora Xi New Nomogram Software 2.0

October 29, 2025 updated by: Fenwal, Inc.
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6735

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Lakeland, Florida, United States, 33813
        • BioLife Plasma Services
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • BioLife Plasma Services
    • Utah
      • American Fork, Utah, United States, 84003
        • BioLife Plasma Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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  • Subjects withdrawn by a qualified healthcare provider due to safety concerns.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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
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
Plasma collection with a proprietary plasma collection volume nomogram provides a more individualized approach to determining the volume of plasma collected from each donor.
Active Comparator: Control Group
Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From venipuncture through 72 hours post-donation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Severe Hypotensive Adverse Events Relative to Donor Type
Time Frame: 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).
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.
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
Time Frame: 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).
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.
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)
Time Frame: 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).
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenwal, Inc.

Investigators

  • Study Director: Carrie Pineda, Fresenius Kabi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Actual)

April 19, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAND-004-CMD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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