Phase 3
Completed N=26
Age of Blood in Sickle Cell Transfusion
Source: ClinicalTrials.gov NCT03704922 ↗Enrolled (actual)
26
Serious AEs
30.8%
Results posted
Nov 2024
Primary outcomePrimary: Proportion of Biochemically Old Red Cell Units — 0.71; 0.86 proportion biologically old units — p=0.051
◆ Published Evidence
Emerging
▲ Trending
3citations · ~3 / year
Blood-storage duration affects hematological and metabolic profiles in patients with sickle cell disease receiving transfusions.
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.
Linked Publications (2)
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Blood-storage duration affects hematological and metabolic profiles in patients with sickle cell disease receiving transfusions.
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Red cell physiologic stress results in lower quality transfusions: a randomized trial in adults with sickle cell disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Biochemically Old Red Cell Units |
0.71; 0.86 | 0.051 |
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) and the linked publication. 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.