Fresh Versus Old Red Blood Cells for Transfusion

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Columbia University.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

Columbia University

ClinicalTrials.gov Identifier:

NCT01319552

First received: March 18, 2011

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Purpose

Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on 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. A participant 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.

Condition	Intervention
Transfusion	Procedure: Fresh transfusion Procedure: Old transfusion

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Iron

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Measure of non-transferrin-bound iron [ Time Frame: Up to 72 hours after transfusion ] [ Designated as safety issue: No ]
Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion.

Estimated Enrollment:	22
Study Start Date:	December 2008
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fresh transfusion	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	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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319552

Locations

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

Principal Investigator:

Spitalnik L Spitalnik, MD

Columbia University

More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Oct 20.

Responsible Party:	Steven Spitalnik, Columbia University Medical Center
ClinicalTrials.gov Identifier:	NCT01319552 History of Changes
Other Study ID Numbers:	AAAD3737, R01HL098014
Study First Received:	March 18, 2011
Last Updated:	March 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

red blood cells
transfusion
storage
sickle cell disease
β-thalassemia

ClinicalTrials.gov processed this record on May 22, 2013

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