Evaluation of the Aurora Xi New Nomogram Software 2.0

Not Applicable

Not yet recruiting

• Conditions: Apheresis Related Hypotension

• Registration Number: NCT06122935
• Lead Sponsor: Fenwal, Inc.

Brief Summary

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 Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Study Start: 2023-11-14
• Primary Completion: 2024-06-14
• Study Completion: 2024-08-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 11519

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• Subjects withdrawn by a qualified healthcare provider due to safety concerns.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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Significant Hypotensive Adverse Events	Up to approximately 9 months, depending on time of enrollment into the trial	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 Outcome Measures

Name	Time	Method
Rate of hypotensive severe/injury adverse events (IQPP DAE Classification 1.5 or 1.6)	Up to approximately 9 months, depending on time of enrollment into the trial.	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).
Rate of Severe Hypotensive Adverse Events Relative to Donor Type	Up to approximately 9 months, depending on time of enrollment into the trial.	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).
Rate of Severe Hypotensive Adverse Events Relative to Sex	Up to approximately 9 months, depending on time of enrollment into the trial.	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).
Rate of Severe Hypotensive Adverse Events Relative to Weight	Up to approximately 9 months, depending on time of enrollment into the trial.	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).
Time from start of plasmapheresis procedure to the first SHAE	Up to approximately 9 months, depending on time of enrollment into the trial.	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).
Rate of Severe Hypotensive Adverse Events Relative to Age	Up to approximately 9 months, depending on time of enrollment into the trial.	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).

Trial Locations

Locations (1)

BioLife Plasma Services; 🇺🇸 American Fork, Utah, United States