N/A
Completed N=60
Duration of Red Blood Cell Storage Prior to Transfusion
Iron, Blood Level Abnormal
Source: ClinicalTrials.gov NCT02087514 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Non-transferrin-bound Iron Level (AUC) — 0.5588; 2.839; 3.684; 5.272 microMole*hr/L
Summary
This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. The results from this study will help guide national guidelines for appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food and Drug Administration (FDA) criteria. The overall objective of this research is to improve the safety of refrigerated storage of red blood cells before transfusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-transferrin-bound Iron Level (AUC) |
0.5588; 2.839; 3.684; 5.272; 6.416; 39.24 | — |
Eligibility Criteria
Inclusion Criteria
- 18-65 years old
- Body weight >110 lbs
- Hemoglobin >12.5 g/dL
Exclusion Criteria
- Ineligible for donation based on the New York Blood Center blood donor questionnaire
- Systolic blood pressure >180 or 100 or 100
- Temperature >99.5 F prior to donation
- Temperature >100.4 F or subjective feeling of illness prior to transfusion (this is to avoid having a concurrent illness affect post-transfusion measurements);
- Positive results on standard blood donor infectious disease testing
- Positive urine pregnancy test
Data sourced from ClinicalTrials.gov (NCT02087514). 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.