Clinical trial NCT06602804: Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
Official title: In Vivo 24-Hour Recovery Study of Leukoreduced RBCs Collected on the Trima Accel System Using Non-DEHP Disposable Sets and Stored for 42 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Device Validation of In-vivo Performance
Keywords: Trima
Trima Accel System
Trima Non-DEHP Disposable Sets
Non-DEHP Disposable Sets
di(2-ethylhexyl) phthalate
Non-DEHP
Red Blood Cell
RBC
Auto RBC
24-hour red blood cell recovery
Investigational Non-DEHP Disposable Tubing Sets
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 Criteria:

1. Given written informed consent.
2. Age 18 years or older.
3. Normal health status as per AABB criteria for healthy donor.
4. Able to commit to the study schedule.
5. 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.
6. Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study.
7. 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.
8. Participants must agree to report AEs throughout their participation in the study

Exclusion Criteria:

1. Currently pregnant or nursing females.
2. Serum ferritin less than12 ng/mL
3. Has previously completed this study with data included in the EAS.
4. 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).
5. As determined by the Investigator:

   1. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency \[G6PD\]),
   2. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies,
   3. Clinically significant acute or chronic disease, or
   4. Reported history of hypersensitivity to technetium or chromium
   5. Other unspecified reason that, in the opinion of the Investigator, makes the healthy adult volunteer unsuitable for enrollment.
6. Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for apheresis donors).
7. Previously transfused/reinfused with RBCs within the last 120 days.

Primary outcomes:
measure: Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage
timeFrame: 43 days
measure: Mean 24-hour, Post-transfusion, In Vivo RBC Recovery Percentage After 42-day Storage
timeFrame: 43 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Hoxworth Blood Center, University of Cincinnati College of Medicine
state: Ohio
city: Norfolk
country: United States
facility: American Red Cross, Norfolk Clinical Research Lab
state: Virginia
Study officials:
References: