Evaluation of the Aurora Xi New Nomogram Software 2.0

Apheresis Related Hypotension Clinical Trial

Official title:

Evaluation of the Aurora Xi New Nomogram Software 2.0

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06122935
• Other study ID #: PAND-004-CMD
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: August 14, 2024

Study information

• Verified date: November 2023
• Source: Fenwal, Inc.
• Contact: Jason Friedmann
• Phone: 847-550-5620
• Email: jason.friedmann[@]fresenius-kabi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 11519
• Est. completion date: August 14, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Subjects withdrawn by a qualified healthcare provider due to safety concerns.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

Related Conditions & MeSH terms

• Apheresis Related Hypotension
• Hypotension

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	BioLife Plasma Services	American Fork	Utah
United States	BioLife Plasma Services	Lakeland	Florida
United States	BioLife Plasma Services	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Fenwal, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to approximately 9 months, depending on time of enrollment into the trial
Secondary	Rate of Severe Hypotensive Adverse Events Relative to Donor Type	To determine if the incidence rate of SHAEs per donor status (first-time or repeat donor) observed with the New Nomogram (Test arm) is non-inferior to the incidence rate observed with the Optimized Nomogram (Control arm).	Up to approximately 9 months, depending on time of enrollment into the trial.
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).	Up to approximately 9 months, depending on time of enrollment into the trial.
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).	Up to approximately 9 months, depending on time of enrollment into the trial.
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).	Up to approximately 9 months, depending on time of enrollment into the trial.
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).	Up to approximately 9 months, depending on time of enrollment into the trial.
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).	Up to approximately 9 months, depending on time of enrollment into the trial.