Fresh Versus Old Red Blood Cells for Transfusion

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

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.

Study Overview

• Status: Completed
• Conditions: Iron, Abnormal Blood Level; Other Abnormal Blood Chemistry
• Intervention / Treatment: Procedure: Fresh transfusion; Procedure: Old transfusion

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Spitalnik L Spitalnik, MD, Columbia University

Publications and helpful links

General Publications

• Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: March 18, 2011
• First Posted (Estimate): March 21, 2011

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 15, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: sickle cell disease; transfusion; red blood cells; storage; β-thalassemia; hemoglobin-associated iron
• Other Study ID Numbers: AAAD3737; R01HL098014 (U.S. NIH Grant/Contract)