Actively Recruiting
Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
Led by Jose Cancelas · Updated on 2026-04-16
20
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
Sponsors
J
Jose Cancelas
Lead Sponsor
D
Department of Health and Human Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive alternative to 51 chromium (51Cr) radiolabeling for regulatory pharmacokinetic studies of red blood cell products.
CONDITIONS
Official Title
Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Age 18 years or older, of any gender.
- Normal health status based on medical history and physical exam.
- Males must be taller than 5'1" and weigh more than 130 lbs; females must be taller than 5'5" and weigh more than 150 lbs.
- Complete blood count and serum chemistry values within normal limits or considered not clinically significant by the investigator.
- Hemoglobin levels greater than 13.3 g/dL and hematocrit above 40%.
- Negative blood donor screening tests for HIV, HBV, HCV, HTLV, Syphilis, and WNV at donation.
- Female participants of childbearing potential and male participants agree to use medically acceptable contraception including a barrier method during the study.
- Meet or exceed AABB blood donation guidelines except for travel deferrals as per site SOPs.
You will not qualify if you...
- Known red blood cell disorder affecting RBC survival.
- Treatment with medication known to affect RBC viability.
- Pregnant or nursing females.
- Male or female participants of childbearing potential not using medically acceptable contraception.
- Participation in another clinical trial currently or within the past 28 days.
- Not eligible for double RBC donation per AABB guidelines.
- Received blood transfusion within the past year.
- Known pre-existing antibody to BioRBC.
- Previous infusion of BioRBC at any time.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
2
American Red Cross
Norfolk, Virginia, United States, 23510
Not Yet Recruiting
Research Team
J
Jose A Cancelas-Perez, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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