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Fresh Versus Old Red Blood Cells for Transfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319552
Recruitment Status : Completed
First Posted : March 21, 2011
Results First Posted : June 2, 2015
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven L. Spitalnik, Columbia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Iron, Abnormal Blood Level Other Abnormal Blood Chemistry Procedure: Fresh transfusion Procedure: Old transfusion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion
Study Start Date : December 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Stored transfusion

Procedure: Old transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Other Name: 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 Name: Stored transfusion

Procedure: Old transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Other Name: Stored transfusion


Outcome Measures
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Primary Outcome Measures :
  1. Measure of Non-transferrin-bound Iron [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319552


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Spitalnik L Spitalnik, MD Columbia University
More Information
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Publications of Results:

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Responsible Party: Steven L. Spitalnik, Professor of Pathology, Columbia University
ClinicalTrials.gov Identifier: NCT01319552    
Other Study ID Numbers: AAAD3737
R01HL098014 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2011    Key Record Dates
Results First Posted: June 2, 2015
Last Update Posted: June 2, 2015
Last Verified: May 2015
Keywords provided by Steven L. Spitalnik, Columbia University:
red blood cells
transfusion
storage
 sickle cell disease
β-thalassemia
hemoglobin-associated iron