Fresh Versus Old Red Blood Cells for Transfusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion

Conditions
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Iron, Abnormal Blood Level, Other Abnormal Blood Chemistry

Intervention / Treatment
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* Procedure: Fresh transfusion
* Procedure: Old transfusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fresh transfusion<br>1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions | Procedure: Fresh transfusion<br>* 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions<br>* Other names: Stored transfusion;Procedure: Old transfusion<br>* 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions<br>* Other names: Stored transfusion;|
| Experimental: Old transfusion<br>1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions | Procedure: Fresh transfusion<br>* 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions<br>* Other names: Stored transfusion;Procedure: Old transfusion<br>* 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions<br>* Other names: Stored transfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | four hours after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sickle cell disease, red blood cells, transfusion, storage, β-thalassemia, hemoglobin-associated iron