Device Validation of In-vivo PerformanceNCT06602804

Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study

A study testing Trima Accel Auto RBC Collection in people with Device Validation of In-vivo Performance, run by Terumo BCT at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Device Validation of In-vivo Performance
What is being tested?: Trima Accel Auto RBC Collection
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 2 sitesUnited States
Study dates: 26 Aug 2024to 31 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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.

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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

Who cannot join

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]),

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Hoxworth Blood Center, University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
American Red Cross, Norfolk Clinical Research Lab
Norfolk, Virginia, 23510

Other trials in United States

About this study

Official title: In Vivo 24-Hour Recovery Study of Leukoreduced RBCs Collected on the Trima Accel System Using Non-DEHP Disposable Sets and Stored for 42 Days

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.

Conditions: Device Validation of In-vivo Performance
Being tested: Trima Accel Auto RBC Collection
Keywords: Trima, Trima Accel System, Trima Non-DEHP Disposable Sets, Non-DEHP Disposable Sets, di(2-ethylhexyl) phthalate, Non-DEHP, Red Blood Cell, RBC, Auto RBC, 24-hour red blood cell recovery, Investigational Non-DEHP Disposable Tubing Sets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trima Accel Auto RBC CollectionDevice
This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection.

Study groups in NCT06602804
Study group	Role	What they receive
Healthy adult participants	Experimental	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. Receives: Device: Trima Accel Auto RBC Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 43 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 202431 Jan 2025

First posted19 Sep 2024
Study start26 Aug 2024
Primary completion31 Jan 2025
Study completion31 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Device Validation of In-vivo PerformanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06602804
Sponsor's protocol ID: CTS-5091
Status last verified: Jan 2026
First submitted: 16 Sep 2024
Last updated: 17 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Privacy concerns

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo 24-Hour Recovery Study of Leukoreduced RBCs Collected on the Trima Accel System Using Non-DEHP Disposable Sets and Stored for 42 Days
ClinicalTrials.gov ID: NCT06602804
Acronym / sponsor ID: CTS-5091
Conditions: Device Validation of In-vivo Performance
Keywords: Trima, Trima Accel System, Trima Non-DEHP Disposable Sets, Non-DEHP Disposable Sets, di(2-ethylhexyl) phthalate, Non-DEHP, Red Blood Cell, RBC
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Terumo BCTIndustry (pharma, biotech, devices)
Study start: 26 Aug 2024 (actual)
Primary completion: 31 Jan 2025 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 19 Sep 2024 (actual)
Results: Posted 17 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy adult participants	Experimental	Device: Trima Accel Auto RBC CollectionPerformance 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (12 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trima Accel Auto RBC CollectionThis is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection.	Device	Healthy adult participants

Primary outcome

Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)
Time frame: 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 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)
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method)
Time frame: 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 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)
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method)
Time frame: 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 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)
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method)
Time frame: 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 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)

Results and safety

Results posted to the registry on 17 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Adult Participants	30	25

Primary outcome: Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)

Time frame: 43 days. Count of participants. Unit: Participants

Measure	Healthy Adult Participants n = 25
Single-Label 24-Hour RBC Recovery Successes	24

Healthy Adult Participants: One-Sided 95% Confidence Interval: 96.0

Population analysed: 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.

Primary outcome: Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method)

Time frame: 43 days. Count of participants. Unit: Participants

Measure	Healthy Adult Participants n = 24
Value	22

Healthy Adult Participants: One-Sided 95% Confidence Interval: 91.7

Primary outcome: Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method)

Time frame: 43 days. Mean (Standard Deviation). Unit: % 24-hr RBC Recovery

Measure	Healthy Adult Participants n = 25
Value	84.573 (6.3961)

Primary outcome: Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method)

Time frame: 43 days. Mean (Standard Deviation). Unit: % 24-hr RBC Recovery

Measure	Healthy Adult Participants n = 25
Value	83.752 (6.0094)

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Adult Participants	0 of 30 (0%)	6 of 30 (20%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Privacy concerns

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Trima Accel Auto RBC Collection in people with Device Validation of In-vivo Performance, run by Terumo BCT at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method) (time frame: 43 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.