Blood bag upgrade: new plastic passes 42-Day storage test

NCT ID NCT06602804

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ยท Last updated Jun 27, 2026

Summary

This study checked whether red blood cells collected with a new type of plastic tubing (non-DEHP) and stored for 42 days still work well in the body. 37 healthy adults donated blood, which was stored and then tested for how many red blood cells survived 24 hours after being returned. The goal was to see if the new tubing meets FDA standards for safe transfusion.

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

37 people

The number who actually took part.

Started

Aug 2024

Finished

Jan 2025

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: 1. Given written informed consent. 2. Age 18 years or older. 3. Normal health status as per AABB criteria for healthy donor. 4. Able to commit to the study schedule. 5. Meets the inclusion criteria defined by site SOPs for automated blood component collection systems or whole blood donation. These criteria are based on AABB standards and FDA regulations. a. Note: Participants who are deferred from volunteer community donations due to certain restrictions may participate in the study, as products are not used for allogeneic transfusion; however, sites may or may not implement this depending on their standard procedures. 6. Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study. 7. Female participants of childbearing potential must agree to take a pregnancy test prior to the apheresis procedure and prior to reinfusion of radiolabeled LR-RBCs. 8. Participants must agree to report AEs throughout their participation in the study Exclusion Criteria: 1. Currently pregnant or nursing females. 2. Serum ferritin less than12 ng/mL 3. Has previously completed this study with data included in the EAS. 4. Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical trial). 5. As determined by the Investigator: 1. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency \[G6PD\]), 2. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies, 3. Clinically significant acute or chronic disease, or 4. Reported history of hypersensitivity to technetium or chromium 5. Other unspecified reason that, in the opinion of the Investigator, makes the healthy adult volunteer unsuitable for enrollment. 6. Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for apheresis donors). 7. Previously transfused/reinfused with RBCs within the last 120 days.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • American Red Cross, Norfolk Clinical Research Lab

    Norfolk, Virginia, 23510, United States

  • Hoxworth Blood Center, University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267, United States