Status:
COMPLETED
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
Lead Sponsor:
Cerus Corporation
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 viabil...
Detailed Description
The study will be performed in two stages. Stage 1 is a randomized, 2-period crossover design. Test platelets stored for 7 days will be radiolabeled based on either the BEST or Variant 1 methods (depe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04022889
Start Date
November 5 2019
End Date
April 17 2021
Last Update
October 27 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45221
2
Bloodworks Northwest Research Institute
Seattle, Washington, United States, 98102