Device Validation of In-vivo Performance
Conditions
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
Brief 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.
Interventions
DEVICETrima Accel Auto RBC Collection
This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection.
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. Given written informed consent. 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 site SOPs for automated blood component collection systems or whole blood donation. These criteria are based on AABB standards and FDA regulations. a. 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. 6. Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study. 7. 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. 8. Participants must agree to report AEs throughout their participation in the study
Exclusion criteria
1. Currently pregnant or nursing females. 2. Serum ferritin less than12 ng/mL 3. Has previously completed this study with data included in the EAS. 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 trial). 5. As determined by the Investigator: 1. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency \[G6PD\]), 2. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies, 3. Clinically significant acute or chronic disease, or 4. Reported history of hypersensitivity to technetium or chromium 5. Other unspecified reason that, in the opinion of the Investigator, makes the healthy adult volunteer unsuitable for enrollment. 6. Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for apheresis donors). 7. Previously transfused/reinfused with RBCs within the last 120 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method) | 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) | 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) | 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) | 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) |
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, with 7 (i.e., screen fails) subjects not meeting the study's eligibility criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.5 Years STANDARD_DEVIATION 19.13 |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 27 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 6 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed