An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System

Completed · Not applicable

Conditions studied: Device Validation of In-vivo Performance

In brief

This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.

Key facts

Study ID

NCT05239455

Run by

Terumo BCT

People needed

37

Starts

2021-11-11

Expected to finish

2022-04-30

Last updated by the study team

2025-01-08

Who can join

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

You may qualify if…

• Healthy volunteers, of either gender
• 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 the Blood Center for whole blood donor. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, tattoos or other reasons by PI approval may participate in the study, as products are re-transfused to the autologous donor.
• Participants of childbearing potential (either male or female) must agree to use medically acceptable method of contraception throughout of the study.
• Females of childbearing potential must be willing to take a pregnancy test prior to WB donation and infusion of radiolabeled RBCs.
• Signed and dated informed consent form.

You may not qualify if…

• Pregnant or nursing females.
• Serum ferritin <12 ng/mL
• Has previously completed this study with evaluable data points.
• Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical).
• As determined by the Investigator
• Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, G- 6PD).
• Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies.
• Clinically significant acute or chronic disease
• Reported history of known hypersensitivity to technetium or chromium.
• Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for blood donors).
• Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrollment.

Where it is running

• Hoxworth Blood Center, University of Cincinnati — Cincinnati, Ohio, United States
• Bloodworks Northwest Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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