CompletedNot Applicable

Duration of Red Blood Cell Storage Prior to Transfusion

United States60 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \<90 mm Hg, diastolic blood pressure \>100 or \<50 mm Hg * Heart rate \<50 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

What they're measuring

Non-transferrin-bound Iron Level (AUC)

Timeframe: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion

Trial details

NCT IDNCT02087514

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02

Results submitted2018-02-19

View on ClinicalTrials.gov More Iron, Blood Level Abnormal trials