Status:
COMPLETED
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
Lead Sponsor:
Terumo BCT
Conditions:
Device Validation of In-vivo Performance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
The Reveos® Automated Blood Processing System (Reveos system) is an automated whole blood processing system, not cleared for use in the United States. The Reveos System has been available outside the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05239455
Start Date
November 11 2021
End Date
April 30 2022
Last Update
January 8 2025
Active Locations (2)
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1
Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio, United States, 45267
2
Bloodworks Northwest Research Institute
Seattle, Washington, United States, 98102