Clinical trial NCT06122935: Evaluation of the Aurora Xi New Nomogram Software 2.0
Official title: Evaluation of the Aurora Xi New Nomogram Software 2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apheresis Related Hypotension
Lead sponsor: Fenwal, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 52699
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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* Subjects withdrawn by a qualified healthcare provider due to safety concerns.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.

Primary outcomes:
measure: Rate of Significant Hypotensive Adverse Events
timeFrame: Up to approximately 9 months, depending on time of enrollment into the trial
Secondary outcomes:
measure: Rate of Severe Hypotensive Adverse Events Relative to Donor Type
timeFrame: Up to approximately 9 months, depending on time of enrollment into the trial.
measure: Rate of Severe Hypotensive Adverse Events Relative to Sex
timeFrame: Up to approximately 9 months, depending on time of enrollment into the trial.
measure: Rate of Severe Hypotensive Adverse Events Relative to Age
timeFrame: Up to approximately 9 months, depending on time of enrollment into the trial.
measure: Rate of Severe Hypotensive Adverse Events Relative to Weight
timeFrame: Up to approximately 9 months, depending on time of enrollment into the trial.
measure: Rate of hypotensive severe/injury adverse events (IQPP DAE Classification 1.5 or 1.6)
timeFrame: Up to approximately 9 months, depending on time of enrollment into the trial.
measure: Time from start of plasmapheresis procedure to the first SHAE
timeFrame: Up to approximately 9 months, depending on time of enrollment into the trial.
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: BioLife Plasma Services
state: Florida
city: West Des Moines
country: United States
facility: BioLife Plasma Services
state: Iowa
city: American Fork
country: United States
facility: BioLife Plasma Services
state: Utah
Study officials:
affiliation: Fresenius Kabi
name: Carrie Pineda
role: STUDY_DIRECTOR
References: