Actively Recruiting
A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
Led by Cerus Corporation · Updated on 2025-10-15
70
Participants Needed
2
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.
CONDITIONS
Official Title
A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Complete blood count and serum chemistry values within normal limits or not clinically significant
- Meet FDA, AABB, or institutional guidelines for allogeneic whole blood donation, including viral marker testing
- Meeting allogeneic deferral criteria due to travel, tattoos/piercings, and male-to-male sexual contact may be acceptable at Investigator discretion
- Subjects of childbearing potential must agree to use medically acceptable contraception during the study
- Signed and dated informed consent form
You will not qualify if you...
- History of red blood cell autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
- History of congenital red cell disorders including G-6PD deficiency, sickle cell trait, or thalassemia minor trait
- Positive direct or indirect antiglobulin test at study entry
- Use of immunosuppressive therapy such as oral or IV prednisone within the past 28 days
- Treatment with any medication known to affect red blood cell viability
- Pregnant or nursing females
- Participation in another interventional clinical study currently or investigational drug use within past 28 days
- Less than three months since receiving an infusion of a radiolabeled blood component
- Reenrollment in the same treatment group previously contributed to
- Non-study blood component donation during the study
- Preexisting antibody specific to INTERCEPT red blood cells
- Known hypersensitivity to chromium or technetium
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267
Not Yet Recruiting
2
American Red Cross Research Laboratory
Norfolk, Virginia, United States, 23510
Actively Recruiting
Research Team
M
Margaret Hennig, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here