Phase 3
N=26
Age of Blood in Sickle Cell Transfusion
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT03704922 ↗Enrolled (actual)
26
Serious AEs
30.8%
Results posted
Nov 2024
Primary outcome: Primary: Proportion of Biochemically Old Red Cell Units — 0.71; 0.86 proportion biologically old units — p=0.051
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Transfusion (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Biochemically Old Red Cell Units |
0.71; 0.86 | 0.051 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- age 16 to 60 years
- have diagnosis of sickle cell disease
- receiving outpatient red cell transfusion therapy
- outpatient at the time of transfusion
Exclusion criteria
- history of reactions to transfusion therapy that cannot be adequately managed by antihistamines
- do not have crossmatch compatible red cells
- participation in another therapeutic trial for SCD
- pregnant
- HIV positive
- uncontrolled inter-current illness, or psychiatric illness/social situations that would limit compliance with study requirements.
Data sourced from ClinicalTrials.gov (NCT03704922). 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.