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

NCT06697223 | Completed Phase 2 FDA Device

• 1 other identifier: CLI 00183
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Healthy Subjects

Keywords

INTERCEPT; Recovery; 5 Days; Survival; Radiolabel; Autologous; LED Illuminator; Apheresis Platelets

Outcome Measures

Primary Outcomes (2)

• Post infusion recovery of Test platelets at end of 5 day storage

  After 5 Day Storage

• Post infusion survival of Test platelets at end of 5 Day storage

  After 5 Day Storage

Secondary Outcomes (3)

• 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

Study Arms (1)

Simultaneous administration of Test and Control platelets

OTHER

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

Interventions

INTERCEPT Blood System for Platelets with LED Illuminator DEVICE

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.

Simultaneous administration of Test and Control platelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerus Corporation: lead

Study Sites (2)

American Red Cross Research Laboratory

Norfolk, Virginia, 23510, United States

Location

Bloodworks Northwest Research Institute

Seattle, Washington, 98102, United States

Location

MeSH Terms

Interventions

Platelet Count

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 23, 2025
• Primary Completion: June 2, 2025
• Study Completion: June 13, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-01

Locations

US (2)