Status:
COMPLETED
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
Lead Sponsor:
Terumo BCT
Conditions:
Device Validation of In-vivo Performance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
Eligibility Criteria
Inclusion
- Given written informed consent.
- Age 18 years or older.
- Normal health status as per AABB criteria for healthy donor.
- Able to commit to the study schedule.
- Meets the inclusion criteria defined by site SOPs for automated blood component collection systems or whole blood donation. These criteria are based on AABB standards and FDA regulations.
- a. Note: Participants who are deferred from volunteer community donations due to certain restrictions may participate in the study, as products are not used for allogeneic transfusion; however, sites may or may not implement this depending on their standard procedures.
- Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study.
- Female participants of childbearing potential must agree to take a pregnancy test prior to the apheresis procedure and prior to reinfusion of radiolabeled LR-RBCs.
- Participants must agree to report AEs throughout their participation in the study
Exclusion
- Currently pregnant or nursing females.
- Serum ferritin less than12 ng/mL
- Has previously completed this study with data included in the EAS.
- Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical trial).
- As determined by the Investigator:
- Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency \[G6PD\]),
- Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies,
- Clinically significant acute or chronic disease, or
- Reported history of hypersensitivity to technetium or chromium
- Other unspecified reason that, in the opinion of the Investigator, makes the healthy adult volunteer unsuitable for enrollment.
- Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for apheresis donors).
- Previously transfused/reinfused with RBCs within the last 120 days.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06602804
Start Date
August 26 2024
End Date
January 31 2025
Last Update
April 17 2025
Active Locations (2)
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1
Hoxworth Blood Center, University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
2
American Red Cross, Norfolk Clinical Research Lab
Norfolk, Virginia, United States, 23510