A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated Wit… (NCT06697223) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator.
United States40 participantsStarted 2025-01-23
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 d…
What they're measuring
1
Post infusion recovery of Test platelets at end of 5 day storage
Timeframe: After 5 Day Storage
2
Post infusion survival of Test platelets at end of 5 Day storage