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New software aims to prevent fainting in plasma donors

NCT ID NCT06122935

Disease control Sponsor: Fenwal, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new computer program (nomogram) for the Aurora Xi plasmapheresis system, which collects plasma from donors. The goal was to see if the new software could lower the risk of sudden drops in blood pressure (hypotension) during donation. Over 6,700 donors took part, and researchers compared the rate of serious hypotensive events between the new and old software versions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6,735 people

The number who actually took part.

Started

Nov 2023

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute hypotension hypotensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Apheresis related hypotension

Contacts and locations

Locations

  • BioLife Plasma Services

    Lakeland, Florida, 33813, United States

  • BioLife Plasma Services

    West Des Moines, Iowa, 50266, United States

  • BioLife Plasma Services

    American Fork, Utah, 84003, United States