Trial Outcomes & Findings for Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study (NCT NCT06602804)
NCT ID: NCT06602804
Last Updated: 2026-02-17
Results Overview
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)
COMPLETED
NA
37 participants
43 days
2026-02-17
Participant Flow
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.
37 participants signed consent, with 7 (i.e., screen fails) subjects not meeting the study's eligibility criteria.
Participant milestones
| Measure |
Healthy Adult Participants
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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Healthy Adult Participants
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.
|
|---|---|
|
Overall Study
LR-RBC Collection Procedure Not Completed
|
2
|
|
Overall Study
Autologous Radiolabeled RBC Reinfusion Procedure Not Initiated
|
2
|
|
Overall Study
Non-Evaluable 24-Hour Recovery
|
1
|
Baseline Characteristics
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
Baseline characteristics by cohort
| Measure |
Healthy Adult Participants
n=30 Participants
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.
|
|---|---|
|
Age, Continuous
|
47.5 Years
STANDARD_DEVIATION 19.13 • n=25 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
27 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 43 daysPopulation: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP.
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)
Outcome measures
| Measure |
Healthy Adult Participants
n=25 Participants
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.
|
|---|---|
|
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)
Single-Label 24-Hour RBC Recovery Successes
|
24 Participants
|
PRIMARY outcome
Timeframe: 43 daysPopulation: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP.
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)
Outcome measures
| Measure |
Healthy Adult Participants
n=24 Participants
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.
|
|---|---|
|
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method)
|
22 Participants
|
PRIMARY outcome
Timeframe: 43 daysPopulation: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP.
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)
Outcome measures
| Measure |
Healthy Adult Participants
n=25 Participants
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.
|
|---|---|
|
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method)
|
84.573 % 24-hr RBC Recovery
Standard Deviation 6.3961
|
PRIMARY outcome
Timeframe: 43 daysPopulation: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP.
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)
Outcome measures
| Measure |
Healthy Adult Participants
n=25 Participants
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.
|
|---|---|
|
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method)
|
83.752 % 24-hr RBC Recovery
Standard Deviation 6.0094
|
Adverse Events
Healthy Adult Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Adult Participants
n=30 participants at risk
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.
|
|---|---|
|
General disorders
Puncture site bruise
|
10.0%
3/30 • 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.
Only procedure emergent AEs (PEAEs) were included in the safety evaluation. Collection of PEAEs began at the time of the first exposure to investigational non-DEHP disposable and continued throughout the entire study until study exit or observed related AEs were resolved. Starting with the first baseline procedure, any new event/experience that was not present at baseline, or worsening of an event present at baseline, was considered an AE.
|
|
General disorders
Puncture site haematoma
|
10.0%
3/30 • 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.
Only procedure emergent AEs (PEAEs) were included in the safety evaluation. Collection of PEAEs began at the time of the first exposure to investigational non-DEHP disposable and continued throughout the entire study until study exit or observed related AEs were resolved. Starting with the first baseline procedure, any new event/experience that was not present at baseline, or worsening of an event present at baseline, was considered an AE.
|
Additional Information
Janet Johnson, RAC / Vice President, Global Regulatory, Clinical Affairs & Labeling
Terumo BCT, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Available upon request.
- Publication restrictions are in place
Restriction type: OTHER