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

NCT ID: NCT06602804

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-01-31

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.

Conditions

Device Validation of In-vivo Performance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy adult participants

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.

Group Type: EXPERIMENTAL

Trima Accel Auto RBC Collection

Intervention Type: DEVICE

This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection.

Interventions

Trima Accel Auto RBC Collection

This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection.

Intervention Type: DEVICE

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Terumo BCT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hoxworth Blood Center, University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

American Red Cross, Norfolk Clinical Research Lab

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

CTS-5091

Identifier Type: -

Identifier Source: org_study_id