Blood bag upgrade: new plastic passes 42-Day storage test
NCT ID NCT06602804
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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37 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Jan 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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American Red Cross, Norfolk Clinical Research Lab
Norfolk, Virginia, 23510, United States
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Hoxworth Blood Center, University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States