N/A N=60 Randomized Other

Duration of Red Blood Cell Storage Prior to Transfusion

Iron, Blood Level Abnormal

Bottom Line

View on ClinicalTrials.gov: NCT02087514 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Non-transferrin-bound Iron Level (AUC) — 0.5588; 2.839; 3.684; 5.272 microMole*hr/L

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood Transfusion (Procedure); Packed red blood cells (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Feb 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

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.