In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days
Completed · Phase 2
Conditions studied: Healthy
In brief
The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain sufficient viability for therapeutic transfusion efficacy. The post-infusion recovery and survival of autologous radiolabeled 7 day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to "fresh" autologous radiolabeled platelets (Control) according to FDA guidance for platelet testing (FDA 1999) in Stage 2 of this study protocol. A secondary objective is to compare the recovery and survival results for Test platelets prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for Safer Transfusion Collaboration (BEST) or a variation of the BEST procedure (referred to as Variant 1) in Stage 1 of this study protocol. Cerus has demonstrated that the Variant 1 method, which does not incorporate an initial soft spin in the presence of ACD A, results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure. This comparison will evaluate the hypothesis that preparation methods prior to radiolabeling may influence in vitro quality of the radiolabeled platelets and post-infusion viability outcomes.
Key facts
- Study ID
- NCT04022889
- Run by
- Cerus Corporation
- People needed
- 37
- Starts
- 2019-11-05
- Expected to finish
- 2021-04-17
- Last updated by the study team
- 2022-10-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age greater than or equal to 18 years, of either gender.
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam).
- Meet FDA, AABB, and site guidelines for blood donation and apheresis platelet donation. Travel, tattoos/piercings and/or male to male sexual contact deferrals do not apply.
- Complete blood count (CBC) and serum chemistry values within established reference ranges or within guidelines as above.
- Pre-donation platelet count of more than 150×10\^9 platelets/ L.
- Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV.
- Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. A barrier method of contraception must be included, regardless of other methods.
- Signed and dated informed consent form.
You may not qualify if…
- For participation in Stage 2, received any previous infusion in this study.
- Clinically significant acute or chronic disease (as determined by the Investigator).
- Pregnant or nursing females.
- Subjects of childbearing potential not using effective contraception.
- Disease states or conditions that preclude apheresis platelet donation per AABB reference standards.
- 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)).
- Subjects with positive cocaine and/or amphetamine results from urine drug screen.
- Splenectomized subjects.
- History of known hypersensitivity to indium or chromium.
- Has received an investigational drug within the past 28 days
Where it is running
- Hoxworth Blood Center — Cincinnati, Ohio, United States
- Bloodworks Northwest Research Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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