Duration of Red Blood Cell Storage Prior to Transfusion

N/ACompletedNCT02087514

Columbia University60 enrolled

Overview

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.

Recent studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain parts of the body. The investigators have preliminary data in mice and humans suggesting that delivery of a significant iron load from aged red cells leads to the production of a potentially toxic form of circulating iron called non-transferrin-bound iron. In this prospective study of healthy volunteers, each subject will be randomized to receive transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours after transfusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Iron, Blood Level Abnormal

Interventions

Blood TransfusionPROCEDURE

A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.

Packed red blood cellsOTHER

Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Non-transferrin-bound Iron Level (AUC)

Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).

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

Data from ClinicalTrials.gov

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