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Completed NCT06697223

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

Conditions: Healthy Subjects

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 40
Sponsor: Cerus Corporation

Location: American Red Cross Research Laboratory Norfolk Virginia

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).

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06697223). StuddyBuddy aggregates publicly available trial information.