Fresh Versus Old Red Blood Cells for Transfusion

N/ACompletedNCT01319552

Columbia University14 enrolled

Overview

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.

Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Iron, Abnormal Blood Level

Interventions

Fresh transfusionPROCEDURE

1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions

Old transfusionPROCEDURE

1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions

Eligibility

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

Medical Language ↔ Plain English

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 \<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 * positive results on standard blood donor infectious disease testing * pregnancy.

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Measure of Non-transferrin-bound Iron

Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.

Time frame: four hours after transfusion

Data from ClinicalTrials.gov

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