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:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT01319552
First received: March 18, 2011
Last updated: March 23, 2011
Last verified: March 2011

March 18, 2011
March 23, 2011
December 2008
March 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01319552 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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 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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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
  • Fresh transfusion
    Interventions:
    • Procedure: Fresh transfusion
    • Procedure: Old transfusion
  • Experimental: Old transfusion
    Interventions:
    • Procedure: Fresh transfusion
    • Procedure: Old transfusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
Not Provided
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01319552
AAAD3737, R01HL098014
Yes
Steven Spitalnik, Columbia University Medical Center
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Spitalnik L Spitalnik, MD Columbia University
Columbia University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP