N/A
Completed N=33
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
Device Validation of In-vivo Performance
Source: ClinicalTrials.gov NCT05239455 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage — 23 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage |
23 | — |
| PRIMARY Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage |
83 | — |
Eligibility Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT05239455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.