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

Completed · Not applicable

Conditions studied: Device Validation of In-vivo Performance

In brief

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.

Key facts

Study ID

NCT06602804

Run by

Terumo BCT

People needed

37

Starts

2024-08-26

Expected to finish

2025-01-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hoxworth Blood Center, University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• American Red Cross, Norfolk Clinical Research Lab — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.