Device Validation of In-vivo PerformanceNCT05239455

An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System

A study testing Reveos® Automated Blood Processing System 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 recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage 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?: Reveos® Automated Blood Processing System
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: 11 Nov 2021to 30 Apr 2022
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

Healthy volunteers, of either gender
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 the Blood Center for whole blood donor. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, tattoos or other reasons by PI approval may participate in the study, as products are re-transfused to the autologous donor.
Participants of childbearing potential (either male or female) must agree to use medically acceptable method of contraception throughout of the study.
Females of childbearing potential must be willing to take a pregnancy test prior to WB donation and infusion of radiolabeled RBCs.
Signed and dated informed consent form.

Who cannot join

Pregnant or nursing females.
Serum ferritin <12 ng/mL
Has previously completed this study with evaluable data points.
Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical).
As determined by the Investigator
Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, G- 6PD).

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Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies.
Clinically significant acute or chronic disease
Reported history of known hypersensitivity to technetium or chromium.
Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for blood donors).
Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrollment.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio, 45267
Bloodworks Northwest Research Institute
Seattle, Washington, 98102

Other trials in United States

About this study

Official title: An In Vivo 24-Hour Recovery Study of Leukoreduced RBCs After Automated Separation of Whole Blood by the Reveos System and Storage for 42 Days

This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.

Read the detailed description

The Reveos® Automated Blood Processing System (Reveos system) is an automated whole blood processing system, not cleared for use in the United States. The Reveos System has been available outside the United States since 2012 and is seeking United States Food and Drug Administration (FDA) 510(k) clearance as an automated whole blood processor. The Reveos System is an integrated manufacturing system that processes whole blood (WB) units into blood components and is designed to minimize manual blood processing variables resulting from processing time, product and procedural variability. The Reveos System can simultaneously process up to 4 whole blood units into 4 RBC units, 4 leukoreduced plasma units, and 4 interim platelet units (IPU). The CPD/AS-5 RBC product is leukoreduced and may be stored up to 42 days.

Terumo BCT is seeking 510(k) clearance from FDA/CBER for the Reveos® Automated Blood Processing System (Reveos System). The proposed study will provide validation on the in vivo performance of LR-RBC units derived from WB processed with the Reveos System. The results will provide data as to whether the Reveos System produced LR-RBC can maintain required levels of 24-hour in vivo recovery that meet FDA criteria for RBC.

Conditions: Device Validation of In-vivo Performance
Being tested: Reveos® Automated Blood Processing System
Keywords: Reveos, Reveos Device, Reveos System, Red Blood Cell Storage, Whole Blood Processing, In-vivo 24-hour red blood cell recovery, Reveos System Manager, Reveos SELECT Set US, Reveos In Vivo US

What participants receive

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

Reveos® Automated Blood Processing SystemDevice
This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from WB processed with the Reveos System.

Study groups in NCT05239455
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 1-6°C. Receives: Device: Reveos® Automated Blood Processing System

What is being measured

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

Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage
The primary outcome of this study is to measure mean 24-hour, post-transfusion, in vivo RBC recovery percentage after LR-RBCs derived from WB and processed with the Reveos System have been stored for 42-days at 1-6°C.
The 3 parts of FDA's 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 24 subjects relative to the 1st part of the criteria.
1. The one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% [Allows for low recoveries (<75%) in 2/20 or 3/24 volunteers] - Primary Outcome 1
2. The sample mean of percent recovery ≥ 75% - Primary Outcome 2
3. The sample standard deviation of in vivo 24-hour RBC recovery ≤ 9% - Primary Outcome 2
Measured: 43 days
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage
The primary outcome of this study is to measure mean 24-hour, post-transfusion, in vivo RBC recovery percentage after LR-RBCs derived from WB and processed with the Reveos System have been stored for 42-days at 1-6°C.
The 3 parts of FDA's 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 24 subjects relative to the 1st part of the criteria.
1. The one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% [Allows for low recoveries (<75%) in 2/20 or 3/24 volunteers] - Primary Outcome 1
2. The sample mean of percent recovery ≥ 75% - Primary Outcome 2
3. The sample standard deviation of in vivo 24-hour 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.

11 Nov 202130 Apr 2022

First posted14 Feb 2022
Study start11 Nov 2021
Primary completion30 Apr 2022
Study completion30 Apr 2022

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: NCT05239455
Sponsor's protocol ID: CTS-5085
Status last verified: Apr 2023
First submitted: 3 Jan 2022
Last updated: 8 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An In Vivo 24-Hour Recovery Study of Leukoreduced RBCs After Automated Separation of Whole Blood by the Reveos System and Storage for 42 Days
ClinicalTrials.gov ID: NCT05239455
Acronym / sponsor ID: CTS-5085
Conditions: Device Validation of In-vivo Performance
Keywords: Reveos, Reveos Device, Reveos System, Red Blood Cell Storage, Whole Blood Processing, In-vivo 24-hour red blood cell recovery, Reveos System Manager, Reveos SELECT Set US
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Terumo BCTIndustry (pharma, biotech, devices)
Study start: 11 Nov 2021 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 14 Feb 2022 (actual)
Results: Posted 8 Jan 2025

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 recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.

Detailed description

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: Reveos® Automated Blood Processing SystemPerformance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 1-6°C.

Who may qualify

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

Key inclusion criteria (8 listed)

Healthy volunteers, of either gender
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 the Blood Center for whole blood donor. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, tattoos or other reasons by PI approval may participate in the study, as products are re-transfused to the autologous donor.

Key exclusion criteria (11 listed)

Pregnant or nursing females.
Serum ferritin <12 ng/mL
Has previously completed this study with evaluable data points.
Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical).
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
Reveos® Automated Blood Processing SystemThis is a non-interventional study, observing the in vivo performance of LR-RBC units derived from WB processed with the Reveos System.	Device	Healthy adult participants

Primary outcome

Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage
Time frame: 43 days
The primary outcome of this study is to measure mean 24-hour, post-transfusion, in vivo RBC recovery percentage after LR-RBCs derived from WB and processed with the Reveos System have been stored for 42-days at 1-6°C. The 3 parts of FDA's 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 24 subjects relative to the 1st part of the criteria. 1. The one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% [Allows for low recoveries (<75%) in 2/20 or 3/24 volunteers] - Primary Outcome 1 2. The sample mean of percent recovery ≥ 75% - Primary Outcome 2 3. The sample standard deviation of in vivo 24-hour RBC recovery ≤ 9% - Primary Outcome 2
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage
Time frame: 43 days
The primary outcome of this study is to measure mean 24-hour, post-transfusion, in vivo RBC recovery percentage after LR-RBCs derived from WB and processed with the Reveos System have been stored for 42-days at 1-6°C. The 3 parts of FDA's 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 24 subjects relative to the 1st part of the criteria. 1. The one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% [Allows for low recoveries (<75%) in 2/20 or 3/24 volunteers] - Primary Outcome 1 2. The sample mean of percent recovery ≥ 75% - Primary Outcome 2 3. The sample standard deviation of in vivo 24-hour RBC recovery ≤ 9% - Primary Outcome 2

Results and safety

Results posted to the registry on 8 Jan 2025, 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	33	26

Primary outcome: Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage

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

Measure	Healthy Adult Participants n = 26
Value	23

Healthy Adult Participants: 95% Confidence Interval: 88.5

Population analysed: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with a valid 24-hour recovery endpoint.

Primary outcome: Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage

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

Measure	Healthy Adult Participants n = 26
Value	83 (9)

Population analysed: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with a valid 24-hour recovery endpoint.

Adverse events

Time frame: Adverse event data were collected from the time of signing the informed consent through study completion. 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 33 (0%)	2 of 33 (6.1%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Jose A Cancelas, MD, PhD principal investigator

Hoxworth Blood Center, University of Cincinnati

Moritz Stolla, MD, PhD principal investigator

Bloodworks Northwest Research Institute

James Kelley, MD, PhD study chair

Terumo BCT

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

Questions about this trial

What is this clinical trial studying?

A study testing Reveos® Automated Blood Processing System 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 8 inclusion and 11 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 8 Jan 2025. 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 8 Jan 2025). 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 RBC's in Vivo Recovery After 42-day Storage (time frame: 43 days). The study lists 2 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 NCT05239455.

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 8 Jan 2025.