Evaluation of the Aurora Xi New Nomogram Software 2.0

NCT06122935 | Completed Results DMC FDA Device

• 1 other identifier: PAND-004-CMD
• Study Type: interventional
• Target: 6,735
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Apheresis Related Hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Rate of Severe Hypotensive Adverse Events Relative to Donor Type

  From Venipuncture through 72 Hours post-donation.

• Rate of Severe Hypotensive Adverse Events Relative to Sex

  From venipuncture through 72 hours post-donation.

• Rate of Severe Hypotensive Adverse Events Relative to Age

  From venipuncture through 72 hours post-donation.

• Rate of Severe Hypotensive Adverse Events Relative to Weight

  From venipuncture through 72 hours post-donation.

• Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6)

  From venipuncture through 72 hours post-donation.

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Plasma collection using the marketed (version 1.3) of AuroraXi Plasmapheresis System

Device: Aurora Xi Currently Approved Software 1.3

Interventions

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.

Test Group

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fenwal, Inc.: lead

Study Sites (3)

BioLife Plasma Services

Lakeland, Florida, 33813, United States

Location

BioLife Plasma Services

West Des Moines, Iowa, 50266, United States

Location

BioLife Plasma Services

American Fork, Utah, 84003, United States

Location

Results Point of Contact

• Title: Jason Friedmann
• Organization: Fresenius Kabi

jason.friedmann@fresenius-kabi.com

847-550-2365

Study Officials

• Carrie Pineda

  Fresenius Kabi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: November 27, 2023
• Primary Completion: April 19, 2024
• Study Completion: May 31, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Locations

US (3)