In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 4
- 主要终点
- pH of Platelets at Day 7
研究概览
简要总结
This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.
详细描述
Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device.
Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System.
This study is designed to provide blood centers with the option to use either Isoplate or InterSol when collecting platelets for use with PAS. Terumo BCT is pursuing approval for InterSol Solution in combination with the Trima Accel System.
This is a randomized, paired, prospective, open-label, multi-center study. Up to 120 healthy adult subjects will be enrolled in this study to ensure 60 paired evaluable data points across two Investigational Sites. Evaluable is defined as two completed platelet products with 100mL plasma that do not meet any of the protocol analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures, and protocol exclusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Age 18 years of age or older
- •Meet the inclusion criteria defined by the Investigational Site for an apheresis double platelet with plasma collection on the Trima Accel System. These criteria are based on American Association of Blood Banks (AABB) standards. Note: Subjects who are deferred from volunteer community donations because of travel restrictions, piercings or tattoos may participate in the study.
排除标准
- 未提供
结局指标
主要结局
pH of Platelets at Day 7
时间窗: Day 7
The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH \>6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
pH of Platelets at Day 5
时间窗: Day 5
The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH \>6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
次要结局
- Percent of Platelets Activated as Measured by P-selectin(Day 7)
- Platelet Morphology(Day 7)
- Percent of Platelets Exhibiting Hypotonic Shock Response(Day 7)
- Percent of Extent of Shape Change(Day 7)