Fresh Versus Old Red Blood Cells for Transfusion

Not Applicable

Completed

• Conditions: Other Abnormal Blood Chemistry; Iron, Abnormal Blood Level
• Interventions: Procedure: Fresh transfusion; Procedure: Old transfusion

• Registration Number: NCT01319552
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2008-12
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Results First Submitted: 2014-03-10
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-15
• Last Update Submitted: 2015-05-15
• Results First Posted: 2015-06-02
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fresh transfusion	Old transfusion	1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
Old transfusion	Fresh transfusion	1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Old transfusion	Old transfusion	1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Fresh transfusion	Fresh transfusion	1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions

Primary Outcome Measures

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

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States