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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
- •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
排除标准
- •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]),
- •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.
研究组 & 干预措施
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 2-6°C.
干预措施: Trima Accel Auto RBC Collection (Device)
结局指标
主要结局
Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
次要结局
未报告次要终点