N/A
N=30
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
Device Validation of In-vivo Performance
Bottom Line
View on ClinicalTrials.gov: NCT06602804 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method) — 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trima Accel Auto RBC Collection (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method) |
24 | — |
| PRIMARY Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method) |
22 | — |
| PRIMARY Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method) |
84.573 | — |
| PRIMARY Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method) |
83.752 | — |
Summary
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
Eligibility Criteria
Inclusion Criteria
- Given written informed consent.
- Age 18 years or older.
- Normal health status as per AABB criteria for healthy donor.
- Able to commit to the study schedule.
- 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.
- Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study.
- 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.
- Participants must agree to report AEs throughout their participation in the study
Exclusion Criteria
- Currently pregnant or nursing females.
- Serum ferritin less than12 ng/mL
- Has previously completed this study with data included in the EAS.
- 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).
- As determined by the Investigator:
- Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency [G6PD]),
- Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies,
- Clinically significant acute or chronic disease, or
- Reported history of hypersensitivity to technetium or chromium
- Other unspecified reason that, in the opinion of the Investigator, makes the healthy adult volunteer unsuitable for enrollment.
- Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for apheresis donors).
- Previously transfused/reinfused with RBCs within the last 120 days.
Data sourced from ClinicalTrials.gov (NCT06602804). 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.