The Investigators hypothesize that older red cell units trigger phagocytosis and activation
of circulating macrophages with a downstream immunomodulatory cascade and release of excess
Non Transferrin Bound Iron(NTBI) that leads to increased rates of infection in adults with
Sickle Cell Disease(SCD). To test this hypothesis, the study staff will perform a randomized
prospective clinical trial. In aim 1, the study staff will determine the biochemical
differences between ≥30 day-old versus ≤10 day-old units. In aim 2, the study staff will
determine the physiologic effects of the transfused blood in a patient with SCD. Lastly, in
aim 3, the study staff will explore the clinical implications of receiving older red cells
over a 3 month period.
| David Wichlan | |
| 919-966-6876 | |
| [email protected] |
| Matthew Karafin, MD | |
| 414-937-6809 | |
| [email protected] |
3 United States sites
16 to 45 Years
Phase 2/Phase 3
Interventional
All
Biological
Unknown
1. age 16 to 45 years
2. Hemoglobin SS/Hemoglobin Sβ-thalassemia0
3. on chronic red cell transfusion therapy
4. outpatient at the time of transfusion
1. history of reactions to transfusion therapy that cannot be adequately managed by
antihistamines
2. ≥2 red cell alloantibodies
3. participation in another therapeutic trial for SCD
4. pregnant
5. HIV positive
6. uncontrolled inter-current illness, or psychiatric illness/social situations that
would limit compliance with study requirements.