An In Vivo Recovery and Survival Study of Platelets Collected on the 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
- 33
- 试验地点
- 4
- 主要终点
- Recovered Percentage of the Extrapolated Platelet Count at Time 0
研究概览
简要总结
The purpose of this study is to evaluate the quality of platelets collected on the Trima Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.
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.
Terumo BCT is pursuing FDA clearance for InterSol in combination with the Trima Accel system in order to provide blood centers with the option to use InterSol as well as Isoplate Solution when collecting platelets to be stored in a PAS.
This is a prospective, open-label, multicenter, controlled study. Up to 40 healthy adult subjects will be enrolled in this study to ensure 24 evaluable subjects across two Investigational Sites. Evaluable is defined as the subject completing the recovery and survival procedure and neither the subject or the product meeting any of the Clinical Investigation Plan (CIP) analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures and CIP exclusions.
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
- •Age 18 years or older
- •Normal health status as per AABB criteria for a healthy donor
- •Able to commit to the study schedule
- •Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused
- •Participants of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study
- •Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets
- •Has given written informed consent
排除标准
- •Previously received radiation therapy
- •Has been diagnosed with a platelet disorder (ie, platelet dysfunction)
- •Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year
- •Pregnant or nursing females
- •Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation
- •History of known hypersensitivity to indium or chromium
- •Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (eg, ibuprofen or other NSAIDs)
研究组 & 干预措施
Platelets stored in InterSol
Platelets collected on the Trima Accel system and stored in 65% InterSol/35% plasma
干预措施: Trima Accel system (Device)
结局指标
主要结局
Recovered Percentage of the Extrapolated Platelet Count at Time 0
时间窗: 11 days (+/- 1 day)
The percent recovery of platelets stored in InterSol for 5 Days as compared to fresh controls. Percent recovery was expressed as a percentage and was extrapolated for a value at Time 0. The FDA acceptance criteria for recovery is \>66% of control with a 1-sided 97.5% confidence limit.
Number of Days of Platelet Survival
时间窗: 11 days (+/- 1 day)
Survival of platelets stored in InterSol for 5 Days as compared to fresh controls. Survival was expressed in days and was approximated using linear regression. The FDA acceptance criteria for survival is \>58% of control with a 1-sided 97.5% confidence limit
次要结局
未报告次要终点