18 and older, any sex, with Device Validation of In-vivo Performance. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)Primary· 43 days
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
Group
Value
95% CI
Healthy Adult Participants
24
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method)Primary· 43 days
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
Group
Value
95% CI
Healthy Adult Participants
22
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method)Primary· 43 days
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
Group
Value
95% CI
Healthy Adult Participants
84.573
± 6.3961
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method)Primary· 43 days
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
Group
Value
95% CI
Healthy Adult Participants
83.752
± 6.0094
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Terumo BCT
Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06602804.