Device Validation of In-vivo Performance
Conditions
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
Brief 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.
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.
Interventions
DEVICEReveos® Automated Blood Processing System
This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from WB processed with the Reveos System.
Sponsors
Terumo BCT
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers, of either gender 2. Age 18 years or older. 3. Normal health status as per AABB criteria for healthy donor. 4. Able to commit to the study schedule. 5. 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. 6. Participants of childbearing potential (either male or female) must agree to use medically acceptable method of contraception throughout of the study. 7. Females of childbearing potential must be willing to take a pregnancy test prior to WB donation and infusion of radiolabeled RBCs. 8. Signed and dated informed consent form.
Exclusion criteria
1. Pregnant or nursing females. 2. Serum ferritin \<12 ng/mL 3. Has previously completed this study with evaluable data points. 4. Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical). 5. As determined by the Investigator 1. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, G- 6PD). 2. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies. 3. Clinically significant acute or chronic disease 4. Reported history of known hypersensitivity to technetium or chromium. 5. Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for blood donors). 6. Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
37 participants signed consent and there were 4 screen fails.
Participants by arm
| Arm | Count |
|---|---|
| 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 1-6°C.
Reveos® Automated Blood Processing System: This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from WB processed with the Reveos System. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Incomplete Blood Collection | 1 |
| Overall Study | Sponsor Decision | 5 |
Baseline characteristics
| Characteristic | Healthy Adult Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 41.6 years STANDARD_DEVIATION 17.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 69.15 inches STANDARD_DEVIATION 4.617 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 16 Participants |
| Weight | 192.6 lbs STANDARD_DEVIATION 37.47 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 2 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
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
Time frame: 43 days
Population: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with a valid 24-hour recovery endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Adult Participants | Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage | 83 % 24-hr RBC Recovery | Standard Deviation 9 |
Comparison: The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.
Primary
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
Time frame: 43 days
Population: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with a valid 24-hour recovery endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Adult Participants | Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage | 23 Participants |
Comparison: The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.