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Completed

NCT Number: NCT06122935

Evaluation of the Aurora Xi New Nomogram Software 2.0

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

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Key information

Conditions

Apheresis Related Hypotension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioLife Plasma Services, Lakeland, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Subjects withdrawn by a qualified healthcare provider due to safety concerns.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

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Fenwal, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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