A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 4
- 主要终点
- Donor Postprocedure Platelet Count Following Donation of Single Platelet Product
研究概览
简要总结
The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL.
详细描述
This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.
Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:
- a single platelet product is collected
- a double platelet product is collected, with or without other components.
Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant.
Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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.
- •Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
- •Appears to have adequate venous access to obtain a postprocedure platelet count.
- •Has given written informed consent.
排除标准
- •Has undergone a splenectomy.
研究组 & 干预措施
Single Platelet Product
Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
干预措施: Trima Accel System (Device)
Double Platelet Product
Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
干预措施: Trima Accel System (Device)
结局指标
主要结局
Donor Postprocedure Platelet Count Following Donation of Single Platelet Product
时间窗: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis
The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was \< 100,000 platelets/μL.
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product
时间窗: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis
The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.
次要结局
未报告次要终点