A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator.
Completed · Phase 2
Conditions studied: Healthy Subjects
In brief
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).
Key facts
- Study ID
- NCT06697223
- Run by
- Cerus Corporation
- People needed
- 40
- Starts
- 2025-01-23
- Expected to finish
- 2025-06-12
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- American Red Cross Research Laboratory — Norfolk, Virginia, United States
- Bloodworks Northwest Research Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.