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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: INTERCEPT Blood System for Platelets with LED Illuminator

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 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.

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • American Red Cross Research Laboratory
  • Washington
    • Seattle, Washington, United States, 98102
      • Bloodworks Northwest Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Infusion Recovery of Test Platelets at End of 5 Day Storage	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.	11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets
Post Infusion Survival of Test Platelets at End of 5 Day Storage	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.	11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Dose in Test Component	Percentage of Test components with ≥ 3.0×10^11 platelets	At the end of INTERCEPT treatment on Day 1 or Day 2
Platelet Yield Retention in Test Component	Percentage of Test components with ≥80% platelet yield retention	At the end of INTERCEPT treatment on Day 1 or Day 2
pH 22°C of Test Component	Percentage of Test components with pH 22°C ≥ 6.2	At end of 5 Day storage

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Input Platelet Components: Platelet Dose	Platelet dose was summarized descriptively for the Input components before treatment on Day 0 or Day 1	Before treatment on Day 0 or Day 1
Assessment of the Input Platelet Components: Component Volume	Component volume was summarized descriptively for the Input components before treatment on Day 0 or Day 1	Before treatment on Day 0 or Day 1
Assessment of Test (INTERCEPT) Platelet Component: Component Volume	Component volume was summarized descriptively for Test components after treatment on Day 1 or Day 2	After treatment on Day 1 or Day 2
Assessment of Test (INTERCEPT) Platelet Component: Platelet Dose	Platelet Dose was summarized descriptively for Test components after treatment on Day 1 or Day 2	After treatment on Day 1 or Day 2
Assessment of Test (INTERCEPT) Platelet Component: Platelet Yield Retention	Platelet yield retention was summarized descriptively for Test components after treatment on Day 1 or Day 2	After treatment on Day 1 or Day 2
Assessment of Stored Test (INTERCEPT) Platelet Component: Component Volume	Component volume was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Platelet Count	Platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Platelet Dose	Platelet Dose was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Mean Platelet Volume	Mean Platelet Volume was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: pH	pH was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: pO2	pO2 was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: pO2 Normalized for Platelet Count	pO2 normalized for platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: pCO2	pCO2 was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: pCO2 Normalized for Platelet Count	pCO2 normalized for platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: HCO3	HCO3 was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: HCO3 Normalized to Platelet Count	HCO3 normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Glucose	Supernatant glucose was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Glucose Normalized to Platelet Count	Supernatant glucose normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Lactate	Supernatant lactate was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Lactate Normalized to Platelet Count	Supernatant lactate normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Total ATP	Total ATP was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Total ATP Normalized to Platelet Count	Total ATP normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant LDH Activity	Supernatant LDH activity was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant LDH Normalized to Platelet Count	Supernatant LDH normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Total LDH Activity	Total LDH activity was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant LDH as a % of Total LDH	Supernatant LDH as a % of Total LDH was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: Baseline Adjusted Supernatant LDH as a % of Total LDH	Baseline Adjusted Supernatant LDH as a % of Total LDH was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5
Assessment of Stored Test (INTERCEPT) Platelet Component: P-selectin (CD62P)	P-selectin (CD62P) was summarized descriptively for Test components at end of storage on Day 5	At the end of storage on Day 5

Collaborators and Investigators

• Sponsor: Cerus Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Survival; Recovery; Autologous; INTERCEPT; Radiolabel; 5 Days; LED Illuminator; Apheresis Platelets
• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Function Tests; Blood Cell Count; Platelet Count
• Other Study ID Numbers: CLI 00183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No