NCT06697223

A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cerus Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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 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. 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. Samples for in vitro platelet testing will be collected prior to INTERCEPT treatment (Day 0/1), post INTERCEPT treatment (Day 1/2), and at the end of storage (Day 5). 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 radiochromate (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. Blood samples will be drawn immediately before infusion and for radioactivity measurements at 2 hours ±15 min post-infusion (Day 0), and 6 more samples will be drawn at 1 (within ±4 hours from time of infusion), 2, 3, 5±1, 7/8, and 11±1 days post-infusion (DPI)). The exact time of each sample draw will be recorded. Subjects will be monitored for safety (adverse events including transfusion reactions) from the time of the apheresis procedure until 24 hours after the last DPI blood sample is drawn.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	INTERCEPT Blood System for Platelets with LED Illuminator	Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) using the LED Illuminator and stored for 5 days at 20 to 24°C with continuous agitation.

Timeline

• Start date: 2025-01-23
• Primary completion: 2025-06-02
• Completion: 2025-06-13
• First posted: 2024-11-20
• Last updated: 2026-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study