N/A
Completed N=6,735
Evaluation of the Aurora Xi New Nomogram Software 2.0
Apheresis Related Hypotension
Source: ClinicalTrials.gov NCT06122935 ↗
Enrolled (actual)
6,735
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Rate of Significant Hypotensive Adverse Events — 43; 42 Procedure with a SHAE
Summary
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Significant Hypotensive Adverse Events |
43; 42 | — |
| SECONDARY Rate of Severe Hypotensive Adverse Events Relative to Donor Type |
9; 5 | — |
| SECONDARY Rate of Severe Hypotensive Adverse Events Relative to Sex |
31; 29 | — |
| SECONDARY Rate of Severe Hypotensive Adverse Events Relative to Age |
5; 5 | — |
| SECONDARY Rate of Severe Hypotensive Adverse Events Relative to Weight |
1; 2 | — |
| SECONDARY Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6) |
10; 8 | — |
| SECONDARY Time From Start of Plasmapheresis Procedure to the First SHAE |
44.26; 40.53 | — |
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- Subjects withdrawn by a qualified healthcare provider due to safety concerns.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.
Data sourced from ClinicalTrials.gov (NCT06122935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.