An interventional study of Trima Accel Auto RBC Collection in Device Validation of In-vivo Performance, sponsored by Terumo BCT. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Terumo BCT · Not applicable, Interventional, and Other
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.
Terumo BCT is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
As determined by the Investigator:
Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C.
Device: Trima Accel Auto RBC Collection
This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection.
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
Time frame: 43 days
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method)
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
Time frame: 43 days
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method)
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
Time frame: 43 days
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method)
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
Time frame: 43 days
A donor is considered an "enrolled" participant upon giving informed consent for study participation; this timepoint represents the beginning of a participant's involvement in the study.
| Milestone | Healthy Adult Participants |
|---|---|
| Started | 30 |
| Completed | 25 |
| Not completed | 5 |
| Withdrew: Lr-rbc collection procedure not completed | 2 |
| Withdrew: Autologous radiolabeled rbc reinfusion procedure not initiated | 2 |
| Withdrew: Non-evaluable 24-hour recovery | 1 |
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
| Participants | Healthy Adult Participants |
|---|---|
| Single-Label 24-Hour RBC Recovery Successes | 24 |
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
| Participants | Healthy Adult Participants |
|---|---|
| Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method) | 22 |
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
| % 24-hr RBC Recovery | Healthy Adult Participants |
|---|---|
| Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method) | 84.573 ± 6.3961 |
The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria. 1. A one-sided lower confidence limit for the proportion of RBC components with 24-hour RBC in vivo recovery less than 75% is 70%\* (Primary Outcome 1), \*Allows for low recoveries (\< 75%) in up to 3 out of 24 to 26 participants 2. A sample mean of in vivo 24-hour RBC percent recovery ≥ 75% (Primary Outcome 2) 3. A sample standard deviation of in vivo 24-hour percent RBC recovery ≤ 9% (Primary Outcome 2)
| % 24-hr RBC Recovery | Healthy Adult Participants |
|---|---|
| Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method) | 83.752 ± 6.0094 |
Collected over During a clinical investigation, all AEs occurring from time of exposure to the investigational non-DEHP disposable until end of study participation were recorded. Adverse event assessments occurred at Day 0, Day 42, and Day 43. There was no long-term follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Adult Participants | 0/30 (0%) | 0/30 (0%) | 6/30 (20%) |
| Event | Healthy Adult Participants |
|---|---|
| Puncture site bruiseGeneral disorders | 3/30 |
| Puncture site haematomaGeneral disorders | 3/30 |
| Age, Continuous(Years) | Healthy Adult Participants |
|---|---|
| Mean | 47.5 ± 19.13 |
| Sex: Female, Male(Participants) | Healthy Adult Participants |
|---|---|
| Female | 12 |
| Male | 18 |
| Race/Ethnicity, Customized(Participants) | Healthy Adult Participants |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 27 |
| Not Reported | 1 |
| Unknown | 1 |
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