CompletedNot Applicable

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

United States37 participantsStarted 2021-11-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage

Timeframe: 43 days

Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage

Timeframe: 43 days

Trial details

NCT IDNCT05239455

SponsorTerumo BCT

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-30

Results submitted2023-04-08

View on ClinicalTrials.gov More Device Validation of In-vivo Performance trials