Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study

Terumo

Status: Completed

Conditions: Device Validation of In-vivo Performance

Treatments: Device: Trima Accel Auto RBC Collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06602804

CTS-5091

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Healthy adult participants

Experimental group

Description:

Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C.

Treatment:

Device: Trima Accel Auto RBC Collection