N/A
N=14
Fresh Versus Old Red Blood Cells for Transfusion
Iron, Abnormal Blood Level · Other Abnormal Blood Chemistry
Bottom Line
View on ClinicalTrials.gov: NCT01319552 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Measure of Non-transferrin-bound Iron — 0.16; 3.17 μM
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fresh transfusion (Procedure); Old transfusion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure of Non-transferrin-bound Iron |
0.16; 3.17 | — |
Summary
Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.
Eligibility Criteria
Inclusion Criteria
- healthy
- male body weight >130 lbs, female body weight > 155 lbs
- male height >5'1", female height >5'5"
- hemoglobin >13.3 g/dL
Exclusion Criteria
- ineligible for donation based on the New York Blood Center autologous 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
- positive results on standard blood donor infectious disease testing
- pregnancy.
Data sourced from ClinicalTrials.gov (NCT01319552). 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.