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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
37
This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection.
Hoxworth Blood Center, University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
American Red Cross, Norfolk Clinical Research Lab
Norfolk, Virginia, United States
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)
Time frame: 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)
Time frame: 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)
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Time frame: 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)
Time frame: 43 days