A Randomized, Multi-center, Controlled, In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous Apheresis Platelet Components Suspended in 100% Plasma Treated With the INTERCEPT Blood System for Platelets With LED Illuminator Stored for 5 Days
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Post Infusion Recovery of Test Platelets at End of 5 Day Storage
研究概览
简要总结
The objective of this study is to assess the post-infusion recovery and survival of platelets in 100% Plasma treated with INTERCEPT Blood System for Platelets with LED Illuminator and stored for 5 days after apheresis collection. The post-infusion recovery and survival of autologous radiolabeled 5-day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to fresh autologous radiolabeled platelets (Control).
详细描述
The study population will consist of healthy subjects who meet the FDA, AABB, and site-specific research donor eligibility criteria for an apheresis platelet collection.
Apheresis platelets (single or double) will be collected in 100% plasma on the Trima Accel® Automated Blood Collection system. Each study apheresis collection will be processed using the INTERCEPT Blood System for Platelets; apheresis platelets containing a platelet dose of 4.0 to 5.2 x10^11 platelets in 300 to 390 mL of plasma will be processed using the INTERCEPT Large Volume (LV) processing set. The INTERCEPT process will begin on either the day of collection (Day 0) or the day following collection (Day 1); illumination on the LED Illuminator must occur within 24 hours after the end of collection. Test platelet components will be stored for up to 5 days, after collection, in 100% plasma. In vitro platelet function will be evaluated on pre-treatment (Day 0/1), at the end of INTERCEPT treatment (Day 1/2), and at end of storage (Day 5).
At the end of storage, an aliquot of Test platelets will be aseptically removed from each subject's INTERCEPT platelet storage container and prepared for radiolabeling using Variant 1 BEST version 4.2.1 (Variant 1) method. Variant 1 method does not incorporate an initial soft spin in the presence of ACD A described in the BEST 4.2.1 method which results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure. The method for collection and radiolabeling of the fresh Control platelets in Variant 1 of BEST 4.2.1 contains the same steps as published in the BEST 4.2.1 method (BEST).
The recovery and survival for Test platelets will be compared against the fresh platelet Control. Recovery and survival of INTERCEPT platelets will be assessed after 5 days of storage for up to 24 evaluable subjects.
Test and Control platelets will be randomly radiolabeled with either 51Cr as sodium chromate (Na251CrO4) or 111In as Indium Oxine, depending upon randomization. Subjects will be randomized with equal probability to the radiolabeling sequences (111In/51Cr vs. 51Cr/111In) for Test INTERCEPT platelets/Control fresh platelets. After radiolabeling, the autologous Control and Test platelet samples will be simultaneously infused into the subject.
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
- •Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- •Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
- •Meet FDA, AABB or institutional guidelines for allogeneic and plateletpheresis donor qualifications with the following exceptions:
- •o Deferrals due to travel, tattoos/piercings, male to male sexual contact as institutional policies allow
- •All routine infectious disease testing must be negative or non-reactive (during screening)
- •Subjects of childbearing potential must agree to use a medically acceptable (as per the Investigator) method of contraception throughout the study
- •Signed and dated informed consent form
排除标准
- •Clinically significant acute or chronic disease (as determined by the Investigator)
- •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 (e.g., ibuprofen or other NSAIDs)
- •Subject received platelet inhibitors within 14 days of donation (e.g., clopidogrel, ticlopidine, amphetamines (e.g., Adderall, Dexedrine))
- •Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
- •Treatment with any medication known to affect platelet viability
- •Pregnant or nursing females
- •Received an investigational drug within the past 28 days or current participation in another clinical interventional study
- •Non study blood component donation throughout the study
- •Subjects with positive cocaine and/or amphetamine result from urine drug screen
- •Splenectomized subjects
- •History of known hypersensitivity to 51Chromium or 111Indium
研究组 & 干预措施
Simultaneous administration of Test and Control platelets
INTERCEPT treated platelets (Test) from 24 healthy subjects, stored for 5 days, will be prepared for radiolabeling following the Variant 1 methodology. The radiolabeled autologous Test and Control platelets, approximately 5 to 30 mL, will be simultaneously administered intravenously into the subject.
干预措施: INTERCEPT Blood System for Platelets with LED Illuminator (Device)
结局指标
主要结局
Post Infusion Recovery of Test Platelets at End of 5 Day Storage
时间窗: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets
Recovery of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
Post Infusion Survival of Test Platelets at End of 5 Day Storage
时间窗: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets
Survival of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 \* Control) in survival is greater than or equal to zero.
次要结局
- Platelet Dose in Test Component(At the end of INTERCEPT treatment on Day 1 or Day 2)
- Platelet Yield Retention in Test Component(At the end of INTERCEPT treatment on Day 1 or Day 2)
- pH 22°C of Test Component(At end of 5 Day storage)